A Phase IIIb Study to Characterize the Effectiveness and Safety of Adjuvant Ribociclib in a Wide Patient Population With HR+ HER2- Early Breast Cancer (Adjuvant WIDER)

An open-label, multicenter, phase IIIb, single-arm study to evaluate the safety and efficacy of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free survival (iBCFS), in a wide patient population with HR-positive (HR+), HER2-negative (HER2-), Anatomic Stage Group III, II (subset) or I (high-risk subset as exploratory cohort) early Breast Cancer (EBC)

Start Date30 Apr 2025

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

NCT06223698

/ Not yet recruitingPhase 3IIT

Optimizing Extended Adjuvant Endocrine Therapy in Patients with Breast Cancer: a Registry-based Randomized Clinical Trial - SWE-Switch Breast Cancer Trial

Based on the risk of late recurrence in breast cancer patients with luminal disease with high-risk for recurrence, extended adjuvant endocrine therapy beyond 5 years is recommended as a valid treatment option. In premenopausal women at diagnosis converted to postmenopausal after the first five years of tamoxifen, two treatment strategies for extended adjuvant endocrine therapy are available, namely continuing with tamoxifen or switching to aromatase inhibitors (AI). No randomized evidence does exist and both treatment strategies are used in clinical practice. In postmenopausal women with higher recurrence risk initially treated with AI for five years, extended adjuvant therapy with additional two years of AI has shown to be as effective as additional five years of AI. However, no randomized evidence on whether a switching strategy of five-year extended tamoxifen is better compared to two-year extended AI is available. Both treatment strategies are used in clinical practice.
The primary objective of this register-based randomized trial is to investigate the overall survival between patients treated with switching strategy for extended adjuvant endocrine therapy compared to continuing with the same treatment as the initial 5 years in two different clinical scenarios:
* In premenopausal women at diagnosis who converted to postmenopausal after 5 years of tamoxifen.
* In postmenopausal women at diagnosis.

Start Date02 Jan 2025

Sponsor / Collaborator

Uppsala University Hospital

CTR20244051

/ Active, not recruitingNot Applicable

阿那曲唑片人体生物等效性研究

[Translation] Study on the bioequivalence of anastrozole tablets in healthy volunteers

本试验旨在研究单次空腹和餐后口服海南日中天制药有限公司研制、生产的阿那曲唑片（1 mg）的药代动力学特征；以AstraZeneca Pharmaceuticals LP生产的阿那曲唑片（瑞宁得®，1 mg）为参比制剂，比较两制剂中药动学参数Cmax和AUC0-72，评价两制剂的人体生物等效性。

[Translation]

This study aimed to investigate the pharmacokinetic characteristics of anastrozole tablets (1 mg) developed and produced by Hainan Rizhongtian Pharmaceutical Co., Ltd. after single oral administration on an empty stomach or after a meal; using anastrozole tablets (Arimidex®, 1 mg) produced by AstraZeneca Pharmaceuticals LP as the reference preparation, the pharmacokinetic parameters Cmax and AUC0-72 of the two preparations were compared, and the bioequivalence of the two preparations in humans was evaluated.

Start Date27 Nov 2024

Sponsor / Collaborator

Hainan Rizhongtian Pharmaceutical Co., Ltd.

100 Clinical Results associated with Anastrozole

100 Translational Medicine associated with Anastrozole

100 Patents (Medical) associated with Anastrozole

2,243

Literatures (Medical) associated with Anastrozole

01 Mar 2025·NEUROPHARMACOLOGY

Neuroprotective effects of testosterone on sevoflurane-induced neurotoxicity in testosterone-deprived male mice

Article

Author: Long, Siwen ; Li, Dujuan ; Yu, Yonghao ; Li, Feixiang ; Yu, Jiafeng ; Yang, Yue ; Yang, Yongyan ; Gong, Bingqing

This study aims to investigate whether androgen deprivation, simulating conditions of aging or disease-induced low testosterone levels, increases the susceptibility of male mice to sevoflurane neurotoxicity, and whether testosterone supplementation can reverse the toxic effects of sevoflurane. In here, young male mice were subjected to orchiectomy (ORC) to induce testosterone deprivation. Various techniques, including western blotting, immunofluorescence, Morris Water Maze, Golgi staining, and neuronal signal measurement, were used to evaluate the effects of sevoflurane on long-term (ORC 10 weeks) and short-term (ORC 2 weeks) testosterone deprivation, and assess whether testosterone (1 mg/kg 1 h before sevoflurane exposure) could mitigate sevoflurane-induced neurotoxicity. Flutamide and anastrozole were administered to study testosterone's pathways of action. We found that sevoflurane increased tau phosphorylation and decreased the transient amplitude of Ca²⁺ signals and dendritic spine density in dorsal hippocampal CA1 (dCA1) neurons, leading to cognitive impairment in testosterone-deprived male mice. Testosterone treatment reversed the effects of sevoflurane in short-term testosterone-deprived male mice, but not in long-term testosterone-deprived male mice. Additionally, the neuroprotective effect of testosterone was blocked by flutamide rather than anastrozole. We have discovered for the first time that testosterone can mitigate the sevoflurane-induced neurotoxicity in testosterone-deprived male mice and that there exists a therapeutic time window, which may be mediated by androgen receptors. This may provide new insights into the neuroprotective role of sex hormones.

01 Mar 2025·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Three sample preparation methods for clinical determination of CDK4/6 inhibitors with endocrine therapy in breast cancer patient plasma using LC-MS: Cross-validation (red), ecological (green) and economical (blue) assessment

Article

Author: Mlinarić, Zvonimir ; Turković, Lu ; Sertić, Miranda ; Lovrić, Mila ; Silovski, Tajana ; Nigović, Biljana

Cyclin D-dependent kinase 4/6 inhibitors palbociclib, ribociclib and abemaciclib, in combination with aromatase inhibitors anastrozole and letrozole or oestrogen receptor degrader fulvestrant, are being assessed as candidates for therapeutic drug monitoring. An ideal bioanalytical method for their determination in patient plasma samples is therefore of high interest, as there is no routine reference method yet available in the clinical practice. In this work, three sample preparation approaches - dispersive liquid-liquid microextraction (DLLME), solid-phase extraction (SPE), and newly developed phospholipid removal (PLR) for LC-MS determination of these six drugs are comprehensively assessed. The methods are validated in the clinically relevant linear ranges with remarkable precision (RSD ≤6.9 %) and accuracy (bias -13.6 - 11.8 %). To compare the procedures in a real-world setting, they are applied on 38 samples from breast cancer patients. The differences between paired results are below 20 % for more than 92 % of the repeats and the RSD is ≤13.1 % between the corresponding results. Statistical comparison of the results reveals excellent overall agreement between the methods (Lin's concordance correlation coefficient ≥0.9969, maximal Bland-Altman bias 6.3 %). DLLME proved to be the most ecologically acceptable method due to the high degree of miniaturisation (AGREEprep score 0.44), PLR enabled very high sample throughput and cost-effectiveness (BAGI 72.5), while SPE showed the best analytical performance (redness score 100). All three methods are suitable for their designated purpose, and the choice of the ideal method can be made based on the scope of application, available funds and equipment and desired ecological footprint.

01 Jan 2025·Advances in Radiation Oncology

Case Report of a Woman With Anastrozole-Associated Radiation Recall

Article

Author: Beriwal, Sushil ; Shamsesfandabadi, Parisa ; Patel, Arpeet ; Champ, Colin E ; Eisen, Veronica R

News (Medical) associated with Anastrozole

10 Dec 2024

·www.prnewswire.com

Longer-term Novartis Kisqali® NATALEE data show durable reduction in distant recurrence in broad population of patients with early breast cancer

Reduction in distant recurrence consistently deepened beyond 3-year Kisqali treatment duration in patients with node-positive (N+) and high-risk node-negative (N0) disease, as well as between anatomical stages1 Real-world 5-year distant recurrence data in high-risk patients with HR+/HER2- early breast cancer (EBC), regardless of nodal status, highlights importance of adding a CDK4/6 inhibitor to endocrine therapy for all eligible patients2 Late-breaking Kisqali data presentations at SABCS follow recent FDA and EMA approvals and recognition by NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®*) as only Category 1 preferred adjuvant treatment for both N+ and high-risk N0 disease in combination with AI3 EAST HANOVER, N.J., Dec. 10, 2024 /PRNewswire/ -- Novartis today announced results from an updated analysis of the pivotal Phase III NATALEE trial of Kisqali® (ribociclib) that underscore the extended efficacy beyond the duration of treatment in combination with endocrine therapy (ET). Results showed a sustained reduction in distant recurrence of 28.5% (HR=0.715; 95% CI 0.604-0.847; nominal P<0.0001), compared to ET alone, in patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC)1. Reduction in distant recurrence, known as distant disease-free survival (DDFS), is a decrease in the rate of cancer returning and spreading to other organs. The DDFS with Kisqali was consistent across all pre-specified patient subgroups, including those with node-negative (N0) disease1. These late-breaking data are being presented at the 2024 San Antonio Breast Cancer Symposium (SABCS). "In day-to-day practice, we see a real and persistent risk of breast cancer coming back after early diagnosis, often as metastatic disease," said Paolo Tarantino, M.D., Advanced Fellow at Dana-Farber Cancer Institute and Harvard Medical School. "The latest NATALEE and real-world data presented at SABCS reaffirm we can better address risk of recurrence for all patients at high-risk, including selected patients with node-negative disease, by offering them adjuvant CDK4/6 inhibitor treatment in addition to endocrine therapy." DDFS results across pre-specified subgroups1,4** : Safety remains consistent with previous reports, and no new safety signals were identified5. Adverse events (AEs) of special interest (grade 3 or higher) were neutropenia (44.4%), liver-related AEs (e.g., elevated transaminases) (8.6%), and QT interval prolongation (1.0%)5. Real-World Risk of Distant Recurrence Further, real-world evidence presented at the meeting highlights the relatively high incidence of distant recurrences within 5 years despite ET monotherapy for patients at high-risk, regardless of nodal involvement2. "On the heels of its U.S. FDA and EMA approvals in early breast cancer, it is encouraging to see the continued benefit of adding Kisqali to standard endocrine therapy to help reduce the risk of recurrence," said Jeff Legos, Executive Vice President, Global Head of Oncology Development, Novartis. "These data, together with the recent NCCN Guidelines® Category 1 preferred treatment recommendation for all eligible patients with early breast cancer, reinforce the opportunity to evolve adjuvant treatment to help a broader group of people." Additional research presented at the meeting further demonstrates the ongoing focus of Novartis to advance the care of people with breast cancer, including studies investigating the potential of radioligand therapies in the treatment of metastatic breast cancer (MBC)6. *NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. **The 4-year DDFS analysis was not prespecified and the trial was not powered to demonstrate statistical significance of these results. About NATALEE NATALEE is a global Phase III multi-center, randomized, open-label trial to evaluate the efficacy and safety of Kisqali with ET as an investigational adjuvant treatment versus ET alone in patients with stage II and III HR+/HER2- EBC, being conducted in collaboration with TRIO7,8. The adjuvant ET in both treatment arms was a non-steroidal aromatase inhibitor (NSAI; anastrozole or letrozole) and goserelin if applicable7,8. The primary endpoint of NATALEE is invasive disease-free survival (iDFS) as defined by the Standardized Definitions for Efficacy End Points (STEEP) criteria7,8. A total of 5,101 adult patients with HR+/HER2- EBC across 20 countries were randomized in the trial7,8. About Kisqali® (ribociclib) Kisqali® (ribociclib) is a selective cyclin-dependent kinase inhibitor, a class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated, can enable cancer cells to grow and divide too quickly. Targeting CDK4/6 with enhanced precision may play a role in ensuring that cancer cells do not continue to replicate uncontrollably. Kisqali has been approved as a treatment for breast cancer by regulatory authorities in 99 countries worldwide, including the U.S. FDA and the European Commission9,10. In the US, Kisqali is indicated in combination with an AI as an adjuvant treatment for adults with HR+/HER2- stage II and III early breast cancer at high risk of recurrence, as well as for the treatment of adults with HR+/HER2- advanced or MBC as initial ET; Kisqali is also approved in the metastatic indication in combination with fulvestrant as initial ET or following disease progression on ET in post-menopausal women or in men9. In EBC, ribociclib (Kisqali) is the only CDK4/6 inhibitor recommended by the NCCN Guidelines® for breast cancer for both all node-positive disease as well as for patients with no nodal involvement with high-risk disease characteristics, such as tumor size >5 cm, or for tumors sized 2-5 cm, either Grade 2 with high genomic risk/Ki-67 ≥20% or Grade 33. In MBC, Kisqali has consistently demonstrated statistically significant overall survival benefit across three Phase III trials11-21. The NCCN Guidelines® also recommend ribociclib (Kisqali) as the only Category 1 preferred CDK4/6 inhibitor for first-line treatment of people living with HR+/HER2- when combined with an AI3, making Kisqali the preferred first-line treatment of choice for US prescribers in HR+/HER2- MBC. Kisqali was developed by Novartis under a research collaboration with Astex Pharmaceuticals. Please see full Prescribing Information for Kisqali, available at . About Novartis in Breast Cancer For more than 30 years, Novartis has been at the forefront of driving scientific advancements for people touched by breast cancer and improving clinical practice in collaboration with the global community. With one of the most comprehensive breast cancer portfolios and pipeline, Novartis leads the industry in discovery of new therapies and combinations in HR+/HER2- breast cancer, the most common form of the disease. Indication What is KISQALI? KISQALI® (ribociclib) is a prescription medicine used to treat adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer: in combination with an aromatase inhibitor for stage II and III early breast cancer with a high risk of coming back that has gotten worse or has spread to other parts of the body (advanced or metastatic breast cancer) in combination with: an aromatase inhibitor as the first endocrine-based therapy; or fulvestrant as the first endocrine-based therapy or following disease progression on endocrine therapy It is not known if KISQALI is safe and effective in children. IMPORTANT SAFETY INFORMATION KISQALI may cause serious side effects, including: Lung problems. KISQALI may cause severe or life-threatening inflammation of the lungs during treatment that may lead to death. Tell your health care provider right away if you have any new or worsening symptoms, including: trouble breathing or shortness of breath cough with or without mucus chest pain Severe skin reactions. Tell your health care provider or get medical help right away if you get severe rash or rash that keeps getting worse; reddened skin; flu-like symptoms; skin pain or burning, blistering of the lips, eyes, or mouth, blisters on the skin or skin peeling, with or without fever. Heart rhythm problems (QT prolongation). KISQALI can cause a heart problem known as QT prolongation. This condition can cause an abnormal heartbeat and may lead to death. Your health care provider should check your heart and do blood tests before and during treatment with KISQALI Tell your health care provider right away if you have a change in your heartbeat (a fast or irregular heartbeat), or if you feel dizzy or faint Liver problems. KISQALI can cause serious liver problems. Your health care provider should do blood tests to check your liver before and during treatment with KISQALI. Tell your health care provider right away if you get any of the following signs and symptoms of liver problems: yellowing of your skin or the whites of your eyes (jaundice) dark or brown (tea-colored) urine feeling very tired loss of appetite pain on the upper right side of your stomach area (abdomen) bleeding or bruising more easily than normal Low white blood cell counts (neutropenia). Low white blood cell counts are very common during treatment with KISQALI and may result in infections that may be severe. Your health care provider should check your white blood cell counts before and during treatment with KISQALI. Tell your health care provider right away if you have signs and symptoms of low white blood cell counts or infections, such as fever and chills. Your health care provider may tell you to decrease your dose, temporarily stop, or completely stop taking KISQALI if you develop certain serious side effects during treatment with KISQALI. What should I tell my health care provider before taking KISQALI? Before you take KISQALI, tell your health care provider if you: have any heart problems, including heart failure, irregular heartbeats, and QT prolongation have ever had a heart attack have a slow heartbeat (bradycardia) have high blood pressure that is not controlled have decreased thyroid gland (hypothyroidism) have problems with the amount of potassium, calcium, phosphorus, or magnesium in your blood have fever, chills, or any other signs or symptoms of infection have liver problems have kidney problems are pregnant, or plan to become pregnant. KISQALI can harm your unborn baby If you are able to become pregnant, your health care provider should do a pregnancy test before you start treatment with KISQALI Females who are able to become pregnant and who take KISQALI should use effective birth control during treatment and for at least 3 weeks after the last dose of KISQALI Talk to your health care provider about birth control methods that may be right for you during this time If you become pregnant or think you are pregnant, tell your health care provider right away are breastfeeding or plan to breastfeed. It is not known if KISQALI passes into your breast milk. Do not breastfeed during treatment with KISQALI and for at least 3 weeks after the last dose of KISQALI Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. KISQALI and other medicines may affect each other, causing side effects. Know the medicines you take. Keep a list of them to show your health care provider or pharmacist when you get a new medicine. What should I avoid while taking KISQALI? Avoid eating grapefruit and avoid drinking grapefruit juice during treatment with KISQALI since these may increase the amount of KISQALI in your blood. The most common side effects of KISQALI in people with early breast cancer include: decreased white blood cell counts decreased red blood cell counts increased liver function tests infections increased kidney function test decreased platelet counts nausea headache tiredness The most common side effects of KISQALI in people with advanced or metastatic breast cancer include: decreased white blood cell counts decreased red blood cell counts increased liver function tests infections nausea increased kidney function test tiredness decreased platelet counts diarrhea vomiting headache constipation hair loss cough rash back pain low blood sugar level KISQALI may cause fertility problems in males, which may affect your ability to father a child. Talk to your health care provider if this is a concern for you. Tell your health care provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of KISQALI. For more information, ask your health care provider or pharmacist. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit , or call 1-800-FDA-1088. Please see accompanying full Prescribing Information including Patient Information . Disclaimer This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "may," "could," "would," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this media update, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this media update will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this media update as of this date and does not undertake any obligation to update any forward-looking statements contained in this media update as a result of new information, future events or otherwise. About Novartis Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide. Reimagine medicine with us: Visit us at and , and connect with us on LinkedIn, LinkedIn US, Facebook, X/Twitter, X/Twitter US and Instagram. References Hurvitz S et al. Distant disease-free survival (DDFS) across key subgroups from the phase 3 NATALEE trial of ribociclib (RIB) plus a nonsteroidal aromatase inhibitor (NSAI) in patients with HR+/HER2− early breast cancer (EBC). Presented at the San Antonio Breast Cancer Symposium, December 12, 2024. Texas, USA. Tarantino P et al. Risk of recurrence in real-world (RW) NATALEE- and monarchE-eligible populations of patients with HR+/HER2− early breast cancer (EBC) in an electronic health record (EHR)-derived database. Presented at the San Antonio Breast Cancer Symposium, December 11, 2024. Texas, USA. NCCN Guidelines. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) - Breast Cancer. Accessed December 2024. Hortobagyi G, Stroyakovskiy D, Yardley DA, et al. Ribociclib (RIB) + nonsteroidal aromatase inhibitor (NSAI) as adjuvant treatment in patients with HR+/HER2- early breast cancer: final invasive disease-free survival (iDFS) analysis from the NATALEE trial. Presented at San Antonio Breast Cancer Symposium (SABCS); December 8, 2023; San Antonio, USA. Fasching PA. Adjuvant Ribociclib (RIB) Plus Nonsteroidal Aromatase Inhibitor (NSAI) in Patients (Pts) With HR+/HER2− Early Breast Cancer (EBC): 4-Year Outcomes from the NATALEE Trial. LBA13. Proffered Paper presented at the European Society for Medical Oncology Congress, September 16, 2024. Barcelona, Spain. Campone M et al. Phase I/II study of the novel radioligand therapy [Lu]Lu-NeoB plus capecitabine in patients with ER+/HER2− advanced breast cancer (ABC) with GRPR expression after progression on prior endocrine therapy (ET) plus a CDK4/6 inhibitor (CDK4/6i) for ABC. Presented at the San Antonio Breast Cancer Symposium, December 12, 2024. Texas, USA. Slamon D, Lipatov O, Nowecki Z, et al. Ribociclib plus Endocrine Therapy in Early Breast Cancer. N Engl J Med. 2024;390(12):1080-1091. doi:10.1056/NEJMoa2305488 Clinicaltrials.gov. NCT03701334. A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/ HER2- Early Breast Cancer (NATALEE). Available from: . Accessed December 2024. Kisqali. Prescribing Information (US FDA). Novartis Pharmaceuticals Corporation; 2017. Accessed December 2024. Kisqali. Summary of product characteristics (SmPC). Novartis Europharm Limited; 2017. Accessed December 2024. Yardley DA et al. Pooled exploratory analysis of survival in patients (pts) with HR+/HER2- advanced breast cancer (ABC) and visceral metastases (mets) treated with ribociclib (RIB) + endocrine therapy (ET) in the MONALEESA (ML) trials. Poster presented at the European Society of Medical Oncology Congress. September 9-13, 2022. Paris, France. Neven P et al. Updated overall survival (OS) results from the first-line (1L) population in the Phase III MONALEESA-3 trial of postmenopausal patients with HR+/HER2- advanced breast cancer (ABC) treated with ribociclib (RIB) + fulvestrant (FUL). Mini oral presented at the European Society for Medical Oncology Breast Cancer Congress. May 4, 2022. Paris, France. Hortobagyi GN, Stemmer SM, Burris HA, et al. Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer. N Engl J Med. 2022;386(10):942-950. doi:10.1056/NEJMoa2114663 Hortobagyi GN et al. Overall survival (OS) results from the phase III MONALEESA (ML)-2 trial of postmenopausal patients with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2−) advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib. LBA 17. Proffered paper presented at the European Society of Medical Oncology Congress, September 16-21, 2021. Lugano, Switzerland. Im SA, Lu YS, Bardia A, et al. Overall survival with ribociclib plus endocrine therapy in breast cancer. N Engl J Med. 2019;381(4):307-316. doi:10.1056/NEJMoa1903765 Slamon DJ, Neven P, Chia S, et al. Overall Survival with Ribociclib plus Fulvestrant in Advanced Breast Cancer. N Engl J Med. 2020;382(6):514-524. doi:10.1056/NEJMoa1911149 Slamon DJ et al. Overall survival (OS) results of the Phase III MONALEESA-3 trial of postmenopausal patients (pts) with hormone receptor-positive (HR+), human epidermal growth factor 2-negative (HER2-) advanced breast cancer (ABC) treated with fulvestrant (FUL) ± ribociclib (RIB). LBA7_PR. Presented at the European Society of Medical Oncology Congress, September 29, 2019. Barcelona, Spain. Slamon DJ et al. Updated overall survival (OS) results from the Phase III MONALEESA-3 trial of postmenopausal patients (pts) with HR+/HER2− advanced breast cancer (ABC) treated with fulvestrant (FUL) ± ribociclib (RIB). Presented at the American Society of Clinical Oncology Annual Meeting, June 5, 2021. Chicago, USA. Tripathy D et al. Updated overall survival (OS) results from the phase III MONALEESA-7 trial of pre- or perimenopausal patients with HR+/HER2− advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib. Presented at the San Antonio Breast Cancer Symposium, December 9, 2020. Texas, USA. Yardley D et al. Overall survival (OS) in patients (pts) with advanced breast cancer (ABC) with visceral metastases (mets), including those with liver mets, treated with ribociclib (RIB) plus endocrine therapy (ET) in the MONALEESA (ML) -3 and -7 trials. Presented at the American Society of Clinical Oncology Annual Meeting, June 2020. Chicago, USA. O'Shaughnessy J et al. Overall survival subgroup analysis by metastatic site from the Phase III MONALEESA-2 study of first-line ribociclib + letrozole in postmenopausal patients with HR+/HER2− advanced breast cancer. Presented at the San Antonio Breast Cancer Symposium, December 7-10, 2021. Texas, USA. # # # Novartis Media Relations E-mail: [email protected] North America Michael Meo +1 862 274 5414 Novartis Investor Relations E-mail: [email protected] North America Sloan Simpson +1 862 345 4440 Jonathan Graham +1 201 602 9921 Parag Mahanti +1 973 876 4912 SOURCE Novartis Pharmaceuticals Corporation WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3Drug Approval

29 Nov 2024

·www.echemi.com

Pfizer Partners with China Resources for Operations of Four Oncology Drugs in China!

On November 26, 2024, Pfizer announced a strategic cooperation with China Resources Pharmaceutical Commercial to manage the commercialization of four oncology treatments in China. These medications include Anastrozole, Abiraterone, Palbociclib, and Crizotinib, which will be managed by China Resources. Pfizer’s China President, Peng Zhenke, and China Resources’ Deputy General Manager, Han Yuewei, attended the signing ceremony. Among these drugs, Icotinib and Epirubicin have already been included in the alliance procurement list, while Palbociclib and Crizotinib are subject to national negotiations, resulting in significant price reductions. Palbociclib also appeared in the newly published tenth national procurement list, indicating further price cuts. The collaboration will commence on December 1, with Pfizer working closely with China Resources to ensure a smooth transition for affected employees.

28 Nov 2024

·pipelinereview.com

Novartis Kisqali® receives European Commission approval in a broad population of patients with HR+/HER2- early breast cancer at high risk of recurrence

BASEL, Switzerland I November 27, 2024 I Novartis announced today that the European Commission (EC) has approved Kisqali ® (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (EBC) at high risk of recurrence 1,7 . The approval is based on results from the pivotal Phase III NATALEE trial, which included a broad patient population with HR+/HER2- stage II and III EBC, including those with node-negative disease 2 . The trial showed a significant and clinically meaningful 25.1% (HR=0.749; 95% CI: 0.628, 0.892; P =0.0006) reduction in risk of disease recurrence with adjuvant Kisqali plus endocrine therapy (ET) compared to ET alone 2 . The invasive disease-free survival (iDFS) benefit was consistently observed across all patient subgroups 2 . “For many patients diagnosed with stage II or III HR+/HER2- early breast cancer, the risk of their cancer coming back despite treatment with endocrine therapy remains high, even after decades,” said Michael Gnant, M.D., FACS, FEBS, Professor of Surgery at the Medical University of Vienna, Austria, and President of the Austrian Breast and Colorectal Study Group. “This approval represents a positive milestone for the early breast cancer community in Europe, including physicians who now have a new option to help reduce the risk of recurrence in a broader population of patients.” In addition, Michael Untch, M.D., Professor and Head of the Clinic for Gynecology and Obstetrics, and Director of the Interdisciplinary Breast Cancer Center at Helios Klinikum Berlin-Buch, noted: “Adding a new treatment option to the HR+/HER2- early breast cancer armamentarium is encouraging news for both physicians and their patients – including patients with node-negative disease and additional risk factors. Ribociclib may now help many patients who are at risk of their cancer returning.” Breast cancer is the most commonly diagnosed cancer in Europe 8 , with approximately 70% of cases diagnosed in the early stages of the disease 9 . Despite current treatment options, people with stage II and III HR+/HER2- EBC remain at risk of experiencing a return of their cancer in the long term, often as incurable advanced disease 4,5 . “Breast cancer recurrence can be a lifelong concern for those living with the disease. Patients deserve access to treatment options that help minimize the risk of their cancer coming back and put their mind at ease,” said Iris Zemzoum, M.D., President, Europe, Novartis. “We are proud of this approval, which will help to address a key unmet need and improve health outcomes for a broader population of patients in Europe.” This news follows the recent U.S. Food and Drug Administration (FDA) approval of Kisqali for EBC patients and recommendation as a Category 1 preferred breast cancer adjuvant treatment by the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines ®* ) 10,11 . Kisqali has also achieved the highest score (A) on the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) for EBC 12 . Regulatory review of Kisqali in EBC is ongoing worldwide. Following recent data announcements at ESMO 2024 6 , Novartis will continue to evaluate NATALEE patients for longer-term outcomes, including overall survival. *NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. About NATALEE NATALEE is a global Phase III multi-center, randomized, open-label trial to evaluate the efficacy and safety of Kisqali ® (ribociclib) with ET as an investigational adjuvant treatment versus ET alone in patients with stage II and III HR+/HER2- EBC, being conducted in collaboration with TRIO 2,13 . The adjuvant ET in both treatment arms was a non-steroidal aromatase inhibitor (NSAI; anastrozole or letrozole) and goserelin if applicable 2,13 . The primary endpoint of NATALEE is invasive disease-free survival (iDFS) as defined by the Standardized Definitions for Efficacy End Points (STEEP) criteria 2,13 . A total of 5,101 adult patients with HR+/HER2- EBC across 20 countries were randomized in the trial 2,13 . About Kisqali ® (ribociclib) Kisqali ® (ribociclib) is a selective cyclin-dependent kinase inhibitor, a class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated, can enable cancer cells to grow and divide too quickly. Targeting CDK4/6 with enhanced precision may play a role in ensuring that cancer cells do not continue to replicate uncontrollably. Kisqali has been approved as a treatment for breast cancer by regulatory authorities in more than 100 countries worldwide, including the U.S. FDA and the European Commission 8,14 . In the U.S., Kisqali is indicated in combination with an AI as an adjuvant treatment of adults with HR+/HER2- stage II and III early breast cancer (EBC) at high risk of recurrence, as well as for the treatment of adults with HR+/HER2- advanced or metastatic breast cancer (MBC) as initial ET; Kisqali is also approved in the metastatic indication in combination with fulvestrant as initial ET or following disease progression on ET in post-menopausal women or in men 14 . In the EU, Kisqali is approved in combination with an AI for the adjuvant treatment of patients with HR+/HER2- EBC at high risk of recurrence. In pre- or perimenopausal women, or in men, the AI should be combined with a luteinising hormone-releasing hormone (LHRH) agonist; Kisqali is approved for the treatment of women with HR+/HER2- advanced or MBC in combination with either an AI or fulvestrant as initial ET or following disease progression. In pre- or peri-menopausal women, the ET should be combined with a LHRH 8 . In EBC, it is the only CDK4/6 inhibitor recommended for both all node-positive disease as well as for patients with no nodal involvement with high-risk disease characteristics, such as tumor size >5 cm, or for tumors sized 2-5 cm, either Grade 2 with high genomic risk/Ki-67 ≥20% or Grade 3 8,14 . Kisqali, in combination with an AI, has the highest score (A) on the ESMO-Magnitude of Clinical Benefit Scale for the adjuvant treatment of adults with stage II and III HR+/HER2- EBC, at high risk of recurrence 12 . In MBC, Kisqali has consistently demonstrated statistically significant overall survival benefit across three Phase III trials 15-25 . The NCCN Guidelines ® for breast cancer recommend ribociclib (Kisqali) as the only Category 1 preferred CDK4/6 inhibitor for first-line treatment of people living with HR+/HER2- when combined with an AI, making Kisqali the preferred first-line treatment of choice for U.S. prescribers in HR+/HER2- MBC 26 . In addition, Kisqali has the highest rating of any CDK4/6 inhibitor on the ESMO-Magnitude of Clinical Benefit Scale, achieving a score of five out of five for first-line pre-menopausal patients with HR+/HER2- advanced breast cancer 27 . Further, Kisqali in combination with either letrozole or fulvestrant has uniquely, among other CDK4/6 inhibitors, received a score of four out of five for post-menopausal patients with HR+/HER2- advanced breast cancer treated in the first line 28 . Kisqali was developed by Novartis under a research collaboration with Astex Pharmaceuticals . Please see full Prescribing Information for Kisqali, available at www.Kisqali.com . About Novartis in Breast Cancer For more than 30 years, Novartis has been at the forefront of driving scientific advancements for people touched by breast cancer and improving clinical practice in collaboration with the global community. With one of the most comprehensive breast cancer portfolios and pipeline, Novartis leads the industry in discovery of new therapies and combinations in HR+/HER2- breast cancer, the most common form of the disease . About Novartis Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide. Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn , Facebook , X/Twitter and Instagram . References SOURCE: Novartis

Clinical ResultDrug ApprovalPhase 3

100 Deals associated with Anastrozole

External Link

KEGG	Wiki	ATC	Drug Bank
D00960	Anastrozole	L02BG03	DB01217

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Fibrous Dysplasia, Polyostotic	US	Astrazeneca Plc /Anti Infective Business/	05 Dec 2008
Gynecomastia	US	Astrazeneca Plc /Anti Infective Business/	05 Dec 2008
Breast Cancer	JP	AstraZeneca KK	22 Dec 2000
Metastatic breast cancer	US	ANI Pharmaceuticals, Inc.	01 Sep 2000
Advanced breast cancer	AU	AstraZeneca Pty Ltd.	17 Dec 1996
Early Stage Breast Carcinoma	AU	AstraZeneca Pty Ltd.	17 Dec 1996
Locally advanced breast cancer	US	ANI Pharmaceuticals, Inc.	27 Dec 1995

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Premenopausal breast cancer	Phase 3	JP	AstraZeneca PLC	01 Oct 2007
Breast cancer recurrent	Phase 3	JP	Pfizer Inc.	01 Apr 2005
Growth hormone deficiency	Phase 3	US	AstraZeneca PLC	01 Nov 2001
Estrogen receptor positive breast cancer	Phase 3	US	AstraZeneca PLC	01 Aug 2000
Estrogen receptor positive breast cancer	Phase 3	JP	AstraZeneca PLC	01 Aug 2000
Estrogen receptor positive breast cancer	Phase 3	BE	AstraZeneca PLC	01 Aug 2000
Estrogen receptor positive breast cancer	Phase 3	BR	AstraZeneca PLC	01 Aug 2000
Estrogen receptor positive breast cancer	Phase 3	CA	AstraZeneca PLC	01 Aug 2000
Estrogen receptor positive breast cancer	Phase 3	CZ	AstraZeneca PLC	01 Aug 2000
Estrogen receptor positive breast cancer	Phase 3	FR	AstraZeneca PLC	01 Aug 2000

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00072462 (IBIS-II DCIS, CTgov)	Phase 3	Ductal Carcinoma \| Breast Cancer \| Noninfiltrating Intraductal Carcinoma	2,980	anastrozole (Anastrozole)	luidjqywhl(yivfjcrkoa) = klczvrtmtk wgnspqkfht (dnyngslblc, wioluktfzk - eortbztqav) View more	-	19 Sep 2024
				tamoxifen citrate (Tamoxifen)	luidjqywhl(yivfjcrkoa) = qcfurbafjs wgnspqkfht (dnyngslblc, ibstxlwvcg - ynjnormchh) View more
NCT03229499 (PHANTOM, Pubmed \| Am J Respir Crit Care Med) Manual	Phase 2	Hypertension, Pulmonary post-menopausal	84	Anastrozole 1 mg	gxbrqfeavk(yasneciwge) = gugtfhpwcx mvtabpsgmu (uxuykxpdwj, -32.7 to 16.9)	Negative	15 May 2024
NCT03229499 (PHANTOM, CTgov)	Phase 2	Pulmonary Arterial Hypertension	84	anastrozole (Anastrozole)	xcosoyvqif(pescrbsydg) = mvrhplvfhh flgsqyvqdq (ylxgphmjbx, dimeigqixz - hsmavnfgpj) View more	-	01 May 2024
				Placebo Oral Tablet (Placebo)	xcosoyvqif(pescrbsydg) = oteonicrvd flgsqyvqdq (ylxgphmjbx, bfnwxibgkz - oefyodyghq) View more
NCT03822468 (AMALEE, CTgov)	Phase 2	Advanced cancer \| Hormone receptor positive HER2 negative breast cancer	376	Letrozole+Ribociclib+Goserelin+anastrozole (Ribociclib 400 mg)	bzkffiypwr(vqgnjhzpxg) = lpakhrrful uzzxzhlylz (nhcougdxro, cqxxtcpfev - panwbtirkd) View more	-	05 Apr 2024
				Letrozole+Ribociclib+Goserelin+anastrozole (Ribociclib 600 mg)	bzkffiypwr(vqgnjhzpxg) = zgqzqgvbwo uzzxzhlylz (nhcougdxro, ycclyjlcnh - ivgcqstlep) View more
NCT00295646 (ABCSG-12, CTgov)	Phase 3	Hormone receptor positive breast cancer	1,803	goserelin+zoledronic acid+anastrozole (AZ (Arimidex+Zoledronate))	qdjejyqsbv(qiuozsqrwp) = yjwjfmlqgd rneoayzkif (eizdjwbcdx, malxnpgrnp - uxqabmfrth) View more	-	15 Mar 2024
				goserelin+Tamoxifen+zoledronic acid (TZ (Tamoxifen+Zoledronate))	qdjejyqsbv(qiuozsqrwp) = pdohtgbgjz rneoayzkif (eizdjwbcdx, lqxkbffiqd - afuthonzfu) View more
NCT01953588 (Pubmed)	Phase 3	Estrogen receptor-negative breast cancer Neoadjuvant Ki67	1,362	Anastrozole	iualoxvvfg(gkwsdtnwrj) = crwdspfgjp mnsqzjnngm (nryhgcumar, 15.1 - 22.7)	-	18 Jan 2024
				Fulvestrant	iualoxvvfg(gkwsdtnwrj) = eaqabgnowj mnsqzjnngm (nryhgcumar, 18.9 - 27.1)
NCT03481998 (phase Ib, Pubmed \| Ther Adv Med Oncol)	Phase 1	HR Positive/HER2 Negative/Node positive breast cancer HR-positive \| HER2-negative	-	Dalpiciclib 125 mg	iubaidvfwp(gwycghlgnu) = yhshtmnkpn vcodnqehza (kmycorfywo ) View more	Positive	01 Jan 2024
				Dalpiciclib 150 mg	iubaidvfwp(gwycghlgnu) = hmmmkkkrim vcodnqehza (kmycorfywo ) View more
NCT01674140 (S1207 \| SWOG S1207 \| e3, CTgov)	Phase 3	Hormone receptor positive HER2 negative breast cancer	1,939	placebo+letrozole+tamoxifen citrate+exemestane+leuprolide acetate+goserelin acetate+anastrozole (Placebo)	yszmfxkksr(gayctcqzml) = ntohjyesno icjvxbpkcl (frjiuupove, ptjeknolkd - kfcahfympl) View more	-	20 Dec 2023
				Everolimus (Everolimus)	yszmfxkksr(gayctcqzml) = bdrjkicevy icjvxbpkcl (frjiuupove, nqapibcqqb - deugvpeeql) View more
AASLD2023	Not Applicable	Breast Cancer	233	No hormone therapy	kknoabnlox(shbnuqqnzv) = hfbmutusrk azkbgryubq (ftarfyuwqp ) View more	-	10 Nov 2023
				Anastrozole	kknoabnlox(shbnuqqnzv) = ngrfbgjtfu azkbgryubq (ftarfyuwqp ) View more
NCT04436744 (coopERA Breast Cancer, Pubmed \| Lancet Oncol)	Phase 2	ER-positive/HER2-negative Breast Cancer Neoadjuvant oestrogen receptor-positive \| HER2-negative \| Ki67 score	221	Giredestrant 30 mg	ciancdfsqb(nwtkrtnnvi) = hpkflhwxac nzdtejtijv (kuqodhrcks, -80 to -70)	Positive	01 Sep 2023
				Anastrozole 1 mg	ciancdfsqb(nwtkrtnnvi) = vapeiimieu nzdtejtijv (kuqodhrcks, -73 to -59)

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