Neoadjuvant chemotherapy has become the standard of care for breast cancer patients with large tumors in order to render them operable for mastectomy or, in some cases, for lumpectomy and radiation therapy. Building on this theme, several large hormonal therapies are extensively investigated in the neoadjuvant setting, together with biologic correlates for response and resistance. As a further extension, neoadjuvant therapies with biologic agents are now too, being investigated for biologic evidence of efficacy before large-scale clinical trials of thousands of patients are embarked on. The neoadjuvant setting is especially attractive for these studies for several reasons including early assessment of response to therapy, biopsiable access to the primary tumor, and considerable reduced sample sizes compared to those required in the adjuvant setting. In addition, clinical response to neoadjuvant chemotherapy is a validated surrogate marker for improved survival. It may be used to test the overall efficacy of neoadjuvant treatment regimens and mirrors the effect of therapy on micrometastases setting. In a recent study, good clinical response to neoadjuvant chemotherapy was the only independent variable, by multivariate analysis, associated with decreased risk of death.
GW572016 is a new and promising dual tyrosine kinase inhibitor against HER1/2. Hundreds of patients were treated in phase I and II studies world-wide and results indicate that this reversible, oral small molecule is generally well-tolerated. Studies of neoadjuvant Trastuzumab indicate that HER2 interference leads to significant tumor regression even after 3 weeks of monotherapy. We aim to extend these findings with a novel agent, GW572016 that may be more effective, especially from its in vitro data, and to discover the true response rate to inhibiting HER1/2 signal transduction in breast cancer patients.

Start Date31 Jul 2023

Sponsor / Collaborator

The University of New Mexico

NCT05400902

/ RecruitingPhase 2IIT

Hepatic Arterial Infusion Chemotherapy Combined With Sintilimab and Bevacizumab in the Treatment of Unresectable Intrahepatic Cholangiocarcinoma: A Prospective, Single-Center, Phase II Study

Primary liver cancer is the sixth most common cancer worldwide, including hepatocellular carcinoma and intrahepatic cholangiocarcinoma, of which intrahepatic cholangiocarcinoma accounts for 10%-15%. Surgical resection is the only curative method for ICC, but most patients are diagnosed at an advanced stage, and only 15% of patients can undergo surgical resection. In locally advanced ICC patients without distant metastases, although the tumor was initially assessed as unresectable, these patients may have the opportunity for surgical resection after reducing the size tumor lesion and increasing the remnant liver volume through conversion therapy. The current standard first-line treatment for unresectable ICC is gemcitabine combined with cisplatin, with a median overall survival of only 11.7 months and an ORR of 26.1%. In view of the poor effect of the standard chemotherapy regimen, the NCCN guidelines recommend that patients could participate in clinical study. Hepatic arterial infusion chemotherapy can increase the local blood drug concentration and improve the tumor regression rate. By reducing the dose of systemic chemotherapy drugs concentration, the incidence of adverse reactions can be reduced. Hepatic arterial infusion chemotherapy may be a better choice for locally advanced intrahepatic cholangiocarcinoma. PD-1 immunotherapy combined with targeted therapy is expected to improve the prognosis of patients with intrahepatic cholangiocarcinoma. This study investigates the safety and efficacy of hepatic arterial infusion chemotherapy combined with sintilimab and bevacizumabin the treatment of unresectable ICC.

Start Date31 May 2023

Sponsor / Collaborator

Sun Yat-Sen University

NCT05290116

/ Unknown statusPhase 2IIT

Hepatic Arterial Infusion Chemotherapy Combined With Tislelizumab and Apatinib in the Treatment of Unresectable Intrahepatic Cholangiocarcinoma: A Prospective, Single-Center, Phase II Study

Primary liver cancer is the sixth most common cancer worldwide, including hepatocellular carcinoma and intrahepatic cholangiocarcinoma, of which intrahepatic cholangiocarcinoma accounts for 10%-15%. Surgical resection is the only curative method for ICC, but most patients are diagnosed at an advanced stage, and only 15% of patients can undergo surgical resection. In locally advanced ICC patients without distant metastases, although the tumor was initially assessed as unresectable, these patients may have the opportunity for surgical resection after reducing the size tumor lesion and increasing the remnant liver volume through conversion therapy. The current standard first-line treatment for unresectable ICC is gemcitabine combined with cisplatin, with a median overall survival of only 11.7 months and an ORR of 26.1%. In view of the poor effect of the standard chemotherapy regimen, the NCCN guidelines recommend that patients could participate in clinical study. Hepatic arterial infusion chemotherapy can increase the local blood drug concentration and improve the tumor regression rate. By reducing the dose of systemic chemotherapy drugs concentration, the incidence of adverse reactions can be reduced. Hepatic arterial infusion chemotherapy may be a better choice for locally advanced intrahepatic cholangiocarcinoma. PD-1 immunotherapy combined with targeted therapy is expected to improve the prognosis of patients with intrahepatic cholangiocarcinoma. This study investigates the safety and efficacy of hepatic arterial infusion chemotherapy combined with tislelizumab and apatinib in the treatment of unresectable ICC.

Start Date21 Jul 2022

Sponsor / Collaborator

Sun Yat-Sen University

100 Clinical Results associated with Lapatinib Ditosylate Hydrate

100 Translational Medicine associated with Lapatinib Ditosylate Hydrate

100 Patents (Medical) associated with Lapatinib Ditosylate Hydrate

5,399

Literatures (Medical) associated with Lapatinib Ditosylate Hydrate

01 Dec 2025·CANCER CHEMOTHERAPY AND PHARMACOLOGY

HER-2 SMASH

Article

Author: Şahin İnan, Zeynep Deniz ; Özkaraca, Mustafa ; Yulak, Fatih ; Altun, Ahmet ; Öztürk, Ayşegül ; Lacın, Burak Batuhan ; Alandağ, Celal

PURPOSE:

Human epidermal growth factor-2 (HER-2) targeted drugs are used in only HER-2 overexpressed cancers. However, only a small portion of these cancer types are HER-2 overexpressed. In this study, we aimed to upregulate HER-2 receptors in MCF-7 breast cancer and HT-29 colon cancer cell cultures, which these cells are not HER-2 upregulated in natural status.

METHODS:

We used a 10-day non-cytotoxic lapatinib dose to upregulate HER-2 receptors. HER-2 levels of these cell lines were tested with ELISA and immunofluorescence tests before and after 10 days of lapatinib administration. After upregulation of HER-2, we administered trastuzumab, and T-DM1 to these cell lines to observe whether there is an increase in anticancer activity. We used a cell viability test to show the cytotoxicity of trastuzumab and T-DM1. Also, we used ELISA and immunofluorescence for HER-2 pathway proteins to understand the mechanism of increased anti-cancer activity.

RESULTS:

We showed that administration of lapatinib for 10 days leads to overexpression of HER-2 receptors on both MCF-7 and HT-29 cells. A significant increase in the cytotoxicity of trastuzumab or T-DM1 was observed after 10 days of lapatinib administration.

CONCLUSION:

We named this method the smash method, which is the volleyball term. In volleyball, the ball is raised while low and quickly hits the ground again, just like we do with the HER-2 receptor. The smash method can switch HER-2 negative or HER-2 low tumors into HER-2 overexpressed, iatrogenically. Thus, we can use her2-targeted therapies in all cancer patients instead of a small portion.

01 Sep 2025·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Discovery and optimization of 2-pyridones as dual h-DHFR/EGFRTK inhibitors with immunomodulatory potential; design, synthesis, anti-proliferative activity, and apoptosis inducer

Article

Author: Ammar, Yousry A ; Raslan, Reham R ; Thabet, Hamdy Khamees ; Gohar, Nirvana A ; Ragab, Ahmed ; Abusaif, Moustafa S

Liver and colorectal cancers present considerable health challenges, underscoring the need to identify innovative targeted therapeutics. Tumor progression can be prevented by targeting EGFR-TK and h-DHFR as essential molecular targets. In this context, we synthesized a new series of 2-pyridones from the reaction of 2-cyanoacrylamide with active methylene or 2-cyanoacetanilide with activated double bonds under basic conditions. The structure of the synthesized 2-pyridones was confirmed through microanalysis and spectroscopic data. In comparison to doxorubicin, the spiro 2-pyridine derivative 9b exhibited the highest anti-proliferative activity, demonstrating IC₅₀ values of 6.89 ± 0.4 μM and 5.68 ± 0.3 μM against HepG-2 and Caco-2 cell lines, respectively, with nearly 2-fold increase in efficacy observed in Caco-2 cells. Additionally, compound 9b demonstrated a significant safety profile concerning normal cells (WI-38), as indicated by selectivity index values of 14.66 and 12.09 against the Caco-2 and HepG-2 cell lines, respectively. Moreover, flow cytometry analysis revealed that compound 9b halted the cell cycle at the G1/S phase in Caco-2 treated cells, demonstrating an increase in the percentage of cells undergoing both early and late apoptosis. The apoptotic potential was corroborated by the up-regulation of BAX and the down-regulation of Bcl-2 levels. Compound 9b exhibited significant inhibitory activity against h-DHFR, with an IC₅₀ value of 0.192 ± 0.011 μM, compared to methotrexate (IC₅₀ = 0.191 ± 0.011 μM). Furthermore, compound 9b demonstrated EGFR inhibitory activity, with IC₅₀ of 0.109 ± 0.005 μM, which is close to the inhibition observed with Lapatinib (IC₅₀ = 0.044 ± 0.002 μM). Compound 9b had better immunomodulatory properties with significant inhibitory efficacy on TNF-α and IL-6, with IC₅₀ values of 0.40 ± 0.03 pg/mL and 0.60 ± 0.02 pg/mL, respectively. These values indicate a greater potency than the positive control drug Lapatinib, which displayed IC₅₀ values of 0.41 ± 0.03 pg/mL and 0.74 ± 0.05 pg/mL for TNF-α and IL-6, respectively. In addition, in silico metabolism prediction using SwissADME and BioTransformer tools revealed that compound 9b is a potential inhibitor of CYP2C9 and CYP3A4, and is predicted to undergo metabolic transformations primarily via aromatic hydroxylation and ketone reduction, while maintaining acceptable stability of its ester moiety. Finally, the molecular docking assessment, together with the direct in vitro enzymatic inhibition results, confirmed that the 2-pyridone derivative 9b can potently bind to and inhibit both EGFR and h-DHFR through favorable binding interactions.

01 Jul 2025·BIOORGANIC CHEMISTRY

Combined PET and near-infrared fluorescence probe based on lapatinib targeting HER2 for in vivo tumor imaging

Article

Author: Gong, Jingyao ; Li, Yunlong ; Li, Jiamin ; Dong, Junming ; He, Congjie ; Cai, Huiming ; Wang, Yiqing ; Di, Hui ; Cao, Peng ; He, Jian

Combination of PET and optical imaging techniques holds significant potential for complete tumor resection to optimize patient outcomes. In this study, we combined two lapatinib-based molecular probes for detecting HER2-overexoression tumors through PET and near-infrared (NIR) fluorescence imaging. HER2 receptor had been confirmed to be overexpressed in many types of tumors and had become a specific target for molecular imaging. The radiolabeled probe [⁶⁸Ga] Ga-NOTA-lapatinib demonstrated superior imaging performance in micro-PET scans, achieving clear differentiation of subcutaneous tumors from adjacent tissues. Complementarily, the NIR fluorescent probe LP-S exhibited prolonged tumor retention (>72 h) with distinct signal demarcation between malignant and normal tissues in ex vivo analyses. Fluorescence microscopy further validated specific intra-tumoral accumulation of the probe at cellular resolution. This synchronized dual-probe strategy, leveraging identical targeting moieties, established a robust platform for multimodality cancer imaging that bridges preoperative detection with intraoperative visualization.

News (Medical) associated with Lapatinib Ditosylate Hydrate

11 Feb 2025

·www.prnewswire.com

New Breast Cancer Therapy to Reduce Risk of Recurrence and Improve Disease-Free Survival Now Approved in Thailand

NERLYNX® (neratinib) has been approved as a single agent for the treatment of early-stage HER2+ breast cancer, and in combination with capecitabine for the treatment of advanced or metastatic HER2+ breast cancer[1] Approval coincides with the first appointment of field force employees, signifying the growth of Specialised Therapeutics in Thailand SINGAPORE, Feb. 11, 2025 /PRNewswire/ -- A NEW breast cancer therapy shown to significantly reduce the risk of cancer recurrence and improve disease-free survival in women is now approved for use in Thailand.[1,2,3] NERLYNX® (neratinib), an oral medication, has been approved by the Thailand Food and Drug Administration (Thailand FDA) as a single agent "for the extended adjuvant treatment of adult patients with early-stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who completed adjuvant trastuzumab-based therapy less than one year ago."[1] Additionally, NERLYNX has been approved in combination with capecitabine"for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting."[1] In early breast cancer, NERLYNX has been shown to significantly reduce the ongoing risk of recurrence in women positive for human epidermal growth factor receptor 2 (HER2+), with the greatest benefit seen in women who are also hormone-receptor positive (HR+) and who commence therapy within 12 months of completing trastuzumab-based therapy.[2,3] For these women, the five-year risk of recurrence is reduced by up to 42%.[4] In women with advanced or metastatic HER2+ breast cancer, NERLYNX in combination with capecitabine (N+C) was found to significantly improve mean progression free survival (PFS) by 2.2 months over treatment with lapatinib plus capecitabine (L+C).[5] The duration of treatment response was longer for patients administered N+C (8.5 months) versus L+C (5.6 months), while the risk of disease progression or death was reduced by up to 24% among those treated with N+C at a median follow-up of 30 months.[5,6] NERLYNX is being made available in Thailand by independent pharmaceutical company, Specialised Therapeutics (ST), under exclusive license from Puma Biotechnology, Inc. ST Chief Executive Officer, Mr Carlo Montagner, said the approval of NERLYNX in Thailand was an important milestone for the company. "We are proud to have obtained approval of NERLYNX in Thailand for adults with HER2 positive breast cancer. This is a significant milestone for Specialised Therapeutics, but importantly also for women diagnosed with breast cancer in Thailand who will be presented with an opportunity to access a treatment that will help reduce the risk of disease recurrence and improve outcomes, in either the early or advanced stages of their disease." Breast cancer is the most common cancer diagnosed in Thai women, and the second leading cause of cancer mortality in females, behind liver cancer.[7] The incidence of breast cancer in Thailand has been rising at an alarming rate, with the annual age-standardised incidence rate doubling over the past 20 years (from 17.8/100,000 in 1998, to 35.7/100,000 in 2020).[8,9] In 2022, 21,628 Thai women were newly diagnosed with breast cancer, accounting for almost a quarter (23.2%) of all new cancer diagnoses in females.[7] Coinciding with the NERLYNX approval, ST is also pleased to announce the growth of its Thailand office, with new field force members due to join the company in March 2025. "We are extremely excited about the new journey we are undertaking in Thailand," said Mr Montagner. "Hiring our first field force employees, who have an extensive understanding of the local healthcare landscape, enables us to connect with oncologists around the country at the earliest opportunity, ahead of launching NERLYNX and making it available for eligible breast cancer patients as soon as possible. "As we continue to seek approvals for our strong pipeline of specialised medicines and technologies, we remain committed to meeting the needs of patients with rare diseases across Thailand, and making a difference to their lives. We look forward to working with the Thailand FDA and local specialists as we endeavour to provide timely access to these new treatments for the patients that need them." Ends. About NERLYNX NERLYNX (neratinib) is an irreversible tyrosine kinase inhibitor (TKI) that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4.[10] It is an oral tablet and works by binding to multiple receptors inside the cancer cell, blocking signals that tell cancer cells to grow and multiply.[11,12] NERLYNX has received approval for the treatment of certain patients with extended adjuvant and/or metastatic HER2-positive breast cancer in more than 40 countries outside the United States (US), including the European Union (EU), China, Latin America, Australia, Canada, and Hong Kong. About HER2-Positive (HER2+) Breast Cancer Approximately 20-25% of breast cancer tumours over-express the HER2 protein. HER2-positive (HER2+) breast cancer is a highly heterogeneous tumour that is often more aggressive than other types of breast cancer and has a poor prognosis, increasing the risk of disease progression and death.[10,13,14] While trastuzumab has helped to improve the survival and prognosis of patients with HER2+ breast cancer, around 20-30% of patients will experience recurrence and metastases after trastuzumab targeted therapy.[14] About the ExteNET Study[2-4,15] The ExteNET trial was a double-blind, placebo-controlled, Phase III trial of neratinib versus placebo after adjuvant treatment with trastuzumab (Herceptin) in patients with early-stage HER2-positive breast cancer. The ExteNET trial randomised 2,840 patients in 41 countries with early-stage HER2-positive breast cancer who had undergone surgery and adjuvant treatment with trastuzumab. After completion of adjuvant treatment with trastuzumab, patients were randomised to receive neratinib or placebo for a period of one year. Patients were then followed for recurrent disease, ductal carcinoma in situ (DCIS), or death for a period of five years after randomisation. The primary endpoint of the trial was invasive disease-free survival (iDFS). The trial demonstrated that after a median follow up of 5.2 years, treatment with neratinib resulted in a 27% reduction of risk of invasive disease recurrence or death versus placebo (hazard ratio = 0.73, p = 0.008). The 5-year iDFS rate for the neratinib arm was 90.2%, versus 87.7% for the placebo arm. An additional five-year sub-group analysis demonstrated a 42% reduction in risk of recurrence and 59% reduction in risk of CNS recurrence or death of any cause in women who were HR+ and who had commenced neratinib therapy within 12 months of completing treatment with trastuzumab. The most common adverse reactions (≥ 5%) were diarrhoea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin, abdominal distention, epistaxis, weight decreased and urinary tract infection. About the NALA Study[5,6] The NALA trial was a randomised, active-controlled, Phase III trial investigating the efficacy of neratinib, an irreversible pan-HER tyrosine kinase inhibitor (TKI), plus capecitabine (N+C) against lapatinib, a reversible dual TKI, plus capecitabine (L+C) in patients with centrally confirmed HER2+ metastatic breast cancer who had received two or more prior anti-HER2 based regimens in the metastatic setting. 621 patients were enrolled at 203 sites in 28 countries across Europe, North and South America, Asia, and Australia. The primary outcome measures for the trial were progression-free survival (PFS), and overall survival (OS). Median PFS was 5.6 months for patients who received N+C and 5.5 months for those receiving L+C (hazard ratio = 0.76, p = 0.0059). The PFS rate at 12 months was 29% versus 15%, respectively. Median OS was 21 months for patients receiving N+C, compared to 18.7 months for those receiving L+C (hazard ratio = 0.88, p = 0.2086). The most common adverse reactions of any grade (>5%) in the N+C arm were diarrhoea, nausea, vomiting, decreased appetite, constipation, fatigue/asthenia, decreased weight, dizziness, back pain, arthralgia, urinary tract infection, upper respiratory tract infection, abdominal distention, renal impairment, and muscle spasms. About Specialised Therapeutics Founded in 2007, Specialised Therapeutics is the region's largest independent specialty pharmaceutical company, providing new therapies and technologies to patients in Australia, New Zealand and across Southeast Asia. Headquartered in Singapore, ST partners with global pharmaceutical, biotech and diagnostic companies to bring novel healthcare opportunities to patients who are impacted by a range of diseases. ST has built a strong track record of success, navigating complex regulatory, reimbursement and commercialisation environments in its diverse regions. The ST mission is to provide specialty therapies where there is an unmet need. The company's broad therapeutic portfolio currently includes novel agents in oncology, haematology, CNS, neurology, endocrinology, ophthalmology and supportive care, although it is not confined to these areas. ST is a member of the World Orphan Drug Alliance (WODA). Additional information can be found at . References: SOURCE Specialised Therapeutics 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 ApprovalOrphan Drug

13 Dec 2024

·endpts.com

Eisai subsidiary nabs Japan rights for schizophrenia drug; Novavax's $50M milestone

Plus, news about Candel, Inovio and RemeGene: Eisai licenses Newron Pharmaceuticals’ evenamide: Eisai’s subsidiary EA Pharma will pay up to €117 million ($123 million) in upfront and milestone fees for rights to the treatment-resistant schizophrenia therapy in Japan and other Asian territories. Newron will continue development elsewhere, with a pivotal trial of the glutamate modulator as an add-on therapy to antipsychotics to start next year. — Elizabeth Cairns Novavax earns a milestone: The Maryland vaccine maker received the first $50 million biobuck payment from Sanofi as part of the pact they announced in May . — Kyle LaHucik Candel priced its $80 million offering at $6 per share $CADL following Phase 3 data earlier this week, and Inovio priced its $30 million offering to fund its DNA medicines. — Kyle LaHucik RemeGen’s ADC succeeds in Phase 3 : Data presented at the San Antonio Breast Cancer Symposium showed disitamab vedotin yielded a 44% reduction in the risk of progression or death in patients with HER2-positive advanced breast cancer with liver metastasis, versus Novartis’ Tykerb plus capecitabine. Progression-free survival with the HER2-targeting conjugate was 9.9 months versus 4.9 months with the Tykerb combo. The company described the PFS benefit as “clinically meaningful”. — Elizabeth Cairns

VaccinePhase 3Clinical Result

12 Dec 2024

·www.prnewswire.com

2024 SABCS｜Results Unveiled for the Phase III Study of Disitamab Vedotin in Treating HER2-Positive Advanced Breast Cancer with Liver Metastasis

YANTAI, China, Dec. 12, 2024 /PRNewswire/ -- On the morning of December 12, 2024 (UTC-6), at the Poster Spotlight Session "Novel HER2 Therapeutics" of the 47th San Antonio Breast Cancer Symposium (SABCS), RemeGen Co. Ltd. ("RemeGen") (9995.HK, 688331.SH) presented for the first time the data from a phase III study (RC48-C006, NCT03500380) of Disitamab Vedotin (DV) in treating patients with HER2-positive advanced breast cancer with liver metastasis (BCLM). This is the first prospective randomized phase III study globally on a HER2-targeting ADC that demonstrated significant efficacy in patients with HER2-positive advanced BCLM. Professor Jiayu Wang from the Cancer Hospital, Chinese Academy of Medical Sciences presented and discussed the study. SABCS is one of the largest and most influential annual conferences focusing on advances in breast cancer clinical research, and this RemeGen sponsored study attracted the attention of experts worldwide. Data shows that about 45% of patients with HER2-positive advanced breast cancer have liver metastasis. This subset has a poor prognosis with a 5-year survival rate of only 8% to 12%, for whom no satisfactory therapies are available now. This is a randomized, open-label, multicenter phase III study comparing the efficacy and safety of DV versus Lapatinib plus Capecitabine in patients with HER2-positive advanced BCLM. A total of 104 patients were enrolled, of whom 53 received DV and 50 received Lapatinib plus Capecitabine. All patients had previously been treated with Trastuzumab and Taxanes. As of data cutoff date (December 31, 2023), according to the assessment by the Independent Review Committee (IRC), DV significantly improved progression-free survival (PFS) versus Lapatinib plus Capecitabine (median: 9.9 months vs. 4.9 months; hazard ratio [HR]: 0.56 [95% CI: 0.35-0.90]), which is consistent with the investigator-assessed PFS (HR: 0.62 [95% CI: 0.39-0.98]). The overall survival (OS) data, though immature, indicated a benefit trend in favor of DV. The safety profile was consistent with past DV use experience, with no new safety signals detected. "This is the first confirmatory phase III study that demonstrated promising efficacy of an HER2-targeting ADC in patients with HER2-positive advanced BCLM," observed Professor Jiayu Wang. DV demonstrated clinically meaningful benefit compared with Lapatinib plus Capecitabine and a manageable safety profile, potentially offering a promising new treatment option for patients with HER2-positive advanced BCLM previously treated with Trastuzumab and Taxanes. The Biologics License Application (BLA) filing for this indication of DV has been accepted by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration in October 2024 and priority review was granted based on the breakthrough therapy designation. SOURCE RemeGen Co., Ltd WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Clinical ResultBreakthrough TherapyPriority ReviewADC

100 Deals associated with Lapatinib Ditosylate Hydrate

External Link

KEGG	Wiki	ATC	Drug Bank
-	Lapatinib Ditosylate Hydrate	L01XE07	DB01259

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Metastatic breast cancer	United States	Novartis Pharmaceuticals Corp.	29 Jan 2010
HER2 Positive Breast Cancer	Switzerland	Novartis AG	23 May 2007
Breast Cancer	United States	Novartis Pharmaceuticals Corp.	13 Mar 2007

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
ER-positive/HER2-positive Breast Cancer	Phase 3	Japan	GlaxoSmithKline (China) Investment Co., Ltd.	05 May 2011
ER-positive/HER2-positive Breast Cancer	Phase 3	Japan	Glaxo Group Ltd.	05 May 2011
ER-positive/HER2-positive Breast Cancer	Phase 3	Argentina	GlaxoSmithKline (China) Investment Co., Ltd.	05 May 2011
ER-positive/HER2-positive Breast Cancer	Phase 3	Argentina	Glaxo Group Ltd.	05 May 2011
ER-positive/HER2-positive Breast Cancer	Phase 3	Belgium	GlaxoSmithKline (China) Investment Co., Ltd.	05 May 2011
ER-positive/HER2-positive Breast Cancer	Phase 3	Belgium	Glaxo Group Ltd.	05 May 2011
ER-positive/HER2-positive Breast Cancer	Phase 3	France	Glaxo Group Ltd.	05 May 2011
ER-positive/HER2-positive Breast Cancer	Phase 3	France	GlaxoSmithKline (China) Investment Co., Ltd.	05 May 2011
ER-positive/HER2-positive Breast Cancer	Phase 3	Greece	Glaxo Group Ltd.	05 May 2011
ER-positive/HER2-positive Breast Cancer	Phase 3	Greece	GlaxoSmithKline (China) Investment Co., Ltd.	05 May 2011

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AACR2025	Not Applicable	Breast Cancer HER2+	-	Compound 17d	usjrygotdt(tqxgazfunn) = rnwzstrqbk ooxngfycbg (scyymimbuy ) View more	-	28 Apr 2025
				Lapatinib	usjrygotdt(tqxgazfunn) = lopziomqaj ooxngfycbg (scyymimbuy ) View more
ESMO_GI2024 Manual	Not Applicable	HER2 positive Biliary Tract Neoplasms Second line HER2 Positive	21	Trastuzumab plus lapatinib	kknhiukndr(wqjlwhrdgu) = mbhyrwwnqq pivlwyexlw (nnyltqetqf, 28.6 - 57.1) View more	Positive	27 Jun 2024
NCT01619111 (DETECT III, Pubmed) Manual	Phase 3	HER2-negative breast cancer \| Circulating Neoplastic Cells HER2 Negative \| HER2 Positive	101	LapatinibLapatinib	qagirkbdca(xllziwjwwn) = ssfcfpuwjp tuuezfialt (eizocrevjx ) View more	Positive	04 Jan 2024
				Standard therapy	qagirkbdca(xllziwjwwn) = hoikkurdmy tuuezfialt (eizocrevjx ) View more
ESMO2023 Manual	Not Applicable	Metastatic human epidermal growth factor 2 positive carcinoma of breast HER2 positive	53	lapatinib or pyrotinib	lixaukfuuq(axsccunuiu) = uamsygwlie ijnrvapmwc (lsblmuaorf, 7.9 - 15.9) View more	Positive	21 Oct 2023
				lapatinib or pyrotinib (brain metastasis)	lixaukfuuq(axsccunuiu) = pptxxkluet ijnrvapmwc (lsblmuaorf, 7.5 - 13.5) View more
ESMO_ASIA2022	Not Applicable	Metastatic human epidermal growth factor 2 positive carcinoma of breast	47	Low dose or metronomic lapatinib (500mg daily with meal)	etuianqmcm(ljjeskaxxb) = tohxvplpml hwbismebqj (abtmwqxjbh ) View more	-	03 Dec 2022
Pubmed Manual	Not Applicable	HER2-positive gastric cancer Third line HER2-Positive	59	Lapatinib Ditosylate Hydrate	cxmdyzniva(eztrtirmah) = ilzeioznud ixawihwmef (ccytocoxil ) View more	Positive	01 Oct 2022
ASCO2022	Not Applicable	Metastatic human epidermal growth factor 2 positive carcinoma of breast	102	Lapatinib and capecitabine combination	cldjtfjhqz(yiclimtyhw) = fktzbqktnr xjionlognr (csnlsqzlht, 5.1 - 10.8)	-	02 Jun 2022
Pubmed Manual	Phase 2	Thymic Epithelial Tumor	25	Lapatinib Ditosylate Hydrate	gpvzihpwrz(azaniigtbf) = nurrzwfmmn ryvssygsjj (qzkmosrcxp, 21 - 61) View more	Positive	10 May 2022
NCT00470704 (TBCRC003 \| TBCRC 003, CTgov)	Phase 2	HER2 Positive Breast Cancer	87	Herceptin+Lapatinib (Cohort 1)	avxzywajoz = dcwiyihuuh xeomtpmern (xjazsbxvrl, grmqqlcxkv - oovohvjmck) View more	-	15 Mar 2022
				Herceptin+Lapatinib (Cohort 2)	avxzywajoz = agsjfinquh xeomtpmern (xjazsbxvrl, qnrqyjatnn - gstcgkqoyp) View more
CRUK/08/002 (SABCS2022)	Not Applicable	HER2 Positive Breast Cancer Ki67	257	Trastuzumab	zajkubhbzs(cgpcoopwfn) = eoeoubugwd gopljfzhms (tnpmzftubf, 76 - 94)	Positive	15 Feb 2022
				Lapatinib	zajkubhbzs(cgpcoopwfn) = toqlnapuhv gopljfzhms (tnpmzftubf, 77 - 96)

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