A Phase I, Open-label, Multi-center Study of Radiation Dosimetry, Safety, and Tolerability of Extended Lutetium (177Lu) Vipivotide Tetraxetan Treatment in Chemo-naïve Adults With Metastatic Castration-resistant Prostate Cancer

The purpose of the study is to assess and evaluate dosimetry, safety, and tolerability following administration of up to 12 cycles of (177Lu) vipivotide tetraxetan (also referred to as [177Lu]Lu-PSMA-617 or 177Lu-PSMA-617 and hereafter identified as AAA617) in taxane-naïve adult participants with PSMA-positive mCRPC who progressed on a prior ARPI treatment with normal renal function or mild renal impairment (eGFR ≥ 60ml/min).

Start Date30 Oct 2024

Sponsor / Collaborator

Novartis Pharmaceuticals Canada, Inc.

NCT05873192 / Not yet recruitingPhase 2IIT

Presurgical Phase II Study of Talazoparib in Combination With Enzalutamide in de Novo Metastatic to Lymph Nodes Prostate Cancer

To learn about the effectiveness of adding talazoparib to the standard of care treatment combination of androgen ablation therapy (hormone therapy, also known as ADT) and enzalutamide in patients with prostate cancer that has spread into the lymph nodes.

Start Date30 Sep 2024

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

NCT04176081 / Not yet recruitingPhase 2IIT

A Prospective, Randomized, Open-label, Multi-centre, Phase II Trial Evaluating IDC/SChLAP1 as a Biomarker for Prediction of Response to Intensified Combined Modality Treatment

Prostate cancer (PCa) is the most frequently diagnosed cancer in men and second leading cause of cancer-related death. Men with PCa have a wide range of possible outcomes if the cancer has not spread and is classified as Intermediate-Risk PCa (IR-PCa).
The standard treatment for IR-PCa is radiation therapy (RT) with or without hormone therapy which can result in cure in some men. In other men, the cancer can come back or spread to other areas of the body. Treatment response in men with IR-PCa is highly variable. This uncertainty has led to significant under- and over-treatment.
This study aims to find out if the addition of intensive treatment (hormonal therapy: darolutamide + degarelix) to standard treatment for PCa will work better than standard treatment alone. To do this, some participants will receive hormone therapy and others will not. All participants will receive RT.
Currently, it is difficult to identify men who may require more intensive therapy. Current methods, such as using prostate specific antigen (PSA) alone, may not give the doctor enough information about who requires more intensive treatment. The researchers conducting this study believe that a particular arrangement of cancer cells [called intraductal carcinoma (IDC)] and the presence of a genetic marker called SChLAP1 can be used to identify people who would benefit from more intensive therapy.
Hormonal therapy such as with drugs called darolutamide (new drug for PCa) and Degarelix, reduce androgens (male hormones, such as testosterone) or block their effect on the cells. PCa cells require androgens to grow and divide, so removal of androgens may be effective in preventing the return of cancer following radiation therapy.
Although darolutamide has been studied in about 1000 men with PCa and seems promising and well tolerated it is considered an experimental drug, therefore it can only be used in a research study such as this one. Degarelix has been approved by Health Canada to treat PCa.
This is a phase 2, open label, randomized, controlled study and will be conducted across sites in Canada. To qualify, men must have IR-PCa and have both SChLAP1 and IDC present or both absent. Participants will be randomized to receive RT with hormone therapy or RT only. The study treatment period is 6 months for the RT + hormone therapy group. RT will take about 1-2 weeks. All participants will be followed for 5 years with multiple visits to assess safety and treatment effects.

Start Date02 Jul 2024

Sponsor / Collaborator

University Health Network

[+2]

100 Clinical Results associated with Degarelix Acetate

100 Translational Medicine associated with Degarelix Acetate

100 Patents (Medical) associated with Degarelix Acetate

316

Literatures (Medical) associated with Degarelix Acetate

01 Dec 2024·MICROBIAL PATHOGENESIS

Degarelix limits the survival of mycobacteria and granuloma formation

Article

Author: Chen, Haizhen ; Yang, Hua ; Gao, Jing ; Huang, Huimin ; Wang, Wenjuan ; Li, Jiaqing ; Shi, Chenyue ; Wang, Jie ; Huang, Xiaochen ; Guo, Xinya ; Gao, Yaxian ; Huang, Jin

Tuberculosis (TB), caused by Mycobacterium tuberculosis (Mtb) infection, is a serious health hazard, characterized by tuberculous granuloma formation, which may facilitate bacterial survival. At the same time, the identification of multidrug-resistant and extremely drug-resistant Mtb strains, and the progressive accumulation of mutations in biological targets of frontline antimicrobials, has made TB treatments more difficult. Therefore, new and rapid drug development for TB is warranted. Recently, drug repurposing has received considerable attention. In this study, we applied the anticancer drug degarelix to anti-TB research and found that it inhibits mycobacteria survival and pathological damage in Mycobacterium marinum-infected zebrafish and Mtb-infected mice. Supplementation of degarelix matched the bactericidal activities of rifampicin (RFP) toward M. marinum in zebrafish. Mechanistically, degarelix significantly increased interferon (IFN)-γ levels in M. marinum-infected zebrafish. Degarelix had no direct anti-mycobacterial activity in vitro but significantly reduced the survival of H37Rv in macrophages. The effect of degarelix could be reversed by 3-methyladenine (3-MA), which inhibits the class III phosphatidylinositol (PI) 3 kinase required for autophagy initiation. However, no effect on later steps in autophagy could be detected. Our findings demonstrate the potential of degarelix on limiting mycobacterial survival and granuloma formation, which may generate novel TB therapeutics.

10 Sep 2024·INTERNATIONAL JOURNAL OF UROLOGY

Dose compliance of estramustine phosphate in neoadjuvant chemohormonal therapy combined with degarelix acetate predicts the biochemical recurrence in patients with very high-risk prostate cancer who underwent robot-assisted radical prostatectomy.

Article

Author: Nagoshi, Akihiko ; Yamamoto, Akihiro ; Murata, Shiori ; Kokubun, Hidetoshi ; Abe, Yohei ; Akagi, Naoki ; Yamasaki, Toshinari ; Hagimoto, Hiroki ; Shibasaki, Noboru ; Tsutsumi, Naofumi ; Kawakita, Mutsushi ; Igarashi, Atsushi ; Fujiwara, Tasuku ; Hattori, Yuto ; Mine, Yuta ; Kambe, Takanari

OBJECTIVES:

The objective of this study is to evaluate the safety and efficacy of neoadjuvant degarelix acetate and low-dose estramustine phosphate for high-/very high-risk prostate cancer.

METHODS:

Overall, 187 patients diagnosed with National Comprehensive Cancer Network high-/very high-risk cTanyN0M0 localized prostate cancer who consented to undergo robot-assisted radical prostatectomy after receiving neoadjuvant chemohormonal therapy for 6 months were prospectively enrolled between December 2017 and March 2023. Adverse events, perioperative and histopathological outcomes, and biochemical recurrence-free survival rates were examined. Survival analysis compared the estramustine phosphate completion and reduction groups.

RESULTS:

Thirty-six patients discontinued neoadjuvant therapy in <5 months owing to adverse events (n = 34) or other reasons (n = 2). Eleven were excluded for being in the postoperative castration range. Of the 140 patients who underwent surgery, 124 continued with two tablets of estramustine phosphate and 16 with one tablet. Overall, 82 patients were very high-risk. Histopathological outcomes were significantly worse in the very high-risk group than those in the high-risk group. Very high-risk status and estramustine phosphate reduction were significant factors in biochemical recurrence in multivariate analysis. The biochemical recurrence-free survival rate in very high-risk patients was significantly lower in the estramustine phosphate dose reduction group than in the completion group but not significant in high-risk patients. Major adverse events were anemia (n = 174), elevated transaminase levels (n = 68), and deep vein thrombosis (n = 24). Severe adverse events included acute coronary syndrome (n = 4) and pulmonary embolism (n = 3).

CONCLUSIONS:

Dose compliance with estramustine phosphate predicted biochemical recurrence in patients with very high-risk prostate cancer undergoing robot-assisted radical prostatectomy with neoadjuvant chemohormonal therapy.

01 Sep 2024·European Urology Oncology

Comparative Cardiovascular Safety of Gonadotropin-releasing Hormone Antagonists and Agonists Among Patients Diagnosed with Prostate Cancer: A Systematic Review and Meta-analysis of Real-world Evidence Studies

Review

Author: Khosrow-Khavar, Farzin ; Dave, Chintan V ; Ghajar, Mina ; Saraiya, Biren ; Dave, Chintan V. ; Bandera, Elisa V. ; Bandera, Elisa V ; Zhu, Kexin ; Patel, Savan ; Zhang, Yingting

BACKGROUND AND OBJECTIVE:

Gonadotropin-releasing hormone (GnRH) antagonists and agonists are cornerstone treatments in prostate cancer. However, evidence regarding the comparative cardiovascular safety of these drugs from clinical trials is inconclusive. The objective of this study was to systematically assess the risk of adverse cardiovascular events of GnRH antagonists compared with GnRH agonists across real-world evidence studies.

METHODS:

We conducted a systematic search of PubMed, Embase, Cochrane Library, Scopus, and Web of Science (2008-2023). We included real-world evidence studies comparing the risk of cardiovascular outcomes of GnRH antagonists with those of GnRH agonists among patients with prostate cancer. We conducted a meta-analysis of effect estimates across studies at a low or moderate risk of bias, assessed via the Risk of Bias in Non-Randomized Studies of Interventions (ROBINS-I) tool, using random-effect models.

KEY FINDINGS AND LIMITATIONS:

Among ten included studies, four were classified as having a moderate and six as having a serious risk of bias. Across three studies at a moderate risk of bias in the primary analysis, degarelix was associated with an increased risk (pooled relative risk [RR]: 1.31, 95% confidence interval [CI]: 1.14-1.51) of major adverse cardiovascular events (MACEs). An augmented risk was observed in two studies among patients with a history of cardiovascular disease (pooled RR: 1.31, 95% CI: 1.11-1.56) compared with one study among patients without a history of cardiovascular disease (RR: 1.15, 95% CI: 0.83-1.59).

CONCLUSIONS AND CLINICAL IMPLICATIONS:

Real-world evidence studies indicate that degarelix, compared with GnRH agonists, is associated with a modest increased risk of MACEs, particularly among patients with a history of cardiovascular disease. However, residual confounding due to the treatment of high-risk patients with degarelix may account for these findings. Additional large studies with detailed data on tumor characteristics and cardiovascular risk factors are needed to confirm these findings.

PATIENT SUMMARY:

In this systematic evaluation of evidence among patients diagnosed with prostate cancer in routine care, degarelix was associated with higher cardiovascular adverse outcomes than gonadotropin-releasing hormone agonists.

News (Medical) associated with Degarelix Acetate

13 Jun 2023

·www.pharmaceutical-technology.com

FDA gives Ferring go-ahead for Adstiladrin gene therapy manufacturing

Ferring Pharmaceuticals, headquarters. A multinational pharmaceutical company that specializes in the development and marketing of drugs for use in human medicine. Copenhagen, Denmark. Credit: oleschwander via Shutterstock The US Food and Drug Administration (FDA) approved Ferring Pharmaceuticals’ Prior-Approval Supplement (PAS) to the Biologics License Application (BLA) for the bladder cancer gene-therapy Adstiladrin (nadofaragene firadenovec). This will allow the Swiss company to begin ramping up its drug substance manufacturing process with its sister company FinVector Oy in Kuopio, Finland ahead of its planned product launch. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. 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British (+1284) Virgin Islands - US (+1340) Wallis & Futuna (+681) Yemen (North)(+969) Yemen (South)(+967) Zambia (+260) Zimbabwe (+263) Country UK USA Afghanistan Åland Islands Albania Algeria American Samoa Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos Islands Colombia Comoros Congo Democratic Republic of the Congo Cook Islands Costa Rica Côte d"Ivoire Croatia Cuba Curaçao Cyprus Czech Republic Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati North Korea South Korea Kuwait Kyrgyzstan Lao Latvia Lebanon Lesotho Liberia Libyan Arab Jamahiriya Liechtenstein Lithuania Luxembourg Macao Macedonia, The Former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia Moldova Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island Northern Mariana Islands Norway Oman Pakistan Palau Palestinian Territory Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Puerto Rico Qatar Réunion Romania Russian Federation Rwanda Saint Helena, Ascension and Tristan da Cunha Saint Kitts and Nevis Saint Lucia Saint Pierre and Miquelon Saint Vincent and The Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and The South Sandwich Islands Spain Sri Lanka Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syrian Arab Republic Taiwan Tajikistan Tanzania Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu Uganda Ukraine United Arab Emirates US Minor Outlying Islands Uruguay Uzbekistan Vanuatu Venezuela Vietnam British Virgin Islands US Virgin Islands Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe Kosovo By downloading this case study, you acknowledge that GlobalData may share your information with GlobalData and that your personal data will be used as described in their Privacy Policy Submit Visit our Privacy Policy for more information about our services, how GlobalData may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. Please check your email to download the Report. The FDA approved Adstiladrin for the treatment of high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors in adult patients in December 2022. This is the first and only FDA-approved intravesical gene therapy for patients with this condition.Ferring Pharmaceuticals has a clinical development pipeline consisting of therapies for reproductive medicine and maternal health, urology and uro-oncology and more. The company currently has five approved therapies in the latter therapy areas, including Firmagon (degarelix) , Minirin (desmopressin), and Testim (testosterone). Ferring plans to begin Adstiladrin production in the H2 2023, as part of an initial rollout in the US. The company aims to then increase supplies in 2024. Finvector Oy is a Finnish biopharmaceutical company that specialises in current Good Manufacturing Practice (cGMP) manufacturing. In May 2022, Finvector began construction of a new viral vector manufacturing site, using the iCELLis manufacturing platform from Pall Corporation. This site will be used for Adstiladrin production. To support the increased capacity, the company expects to hire 500 more employees in the coming years. Non-muscle invasive bladder cancer is characterised by cancer cells that remain only in the lining of the bladder. Common treatment options for the condition include bladder removal surgery, chemotherapy and/or administration of the BCG vaccine in the bladder. Bladder cancer is the sixth most common cancer in the US and the American Society of Clinical Oncology predicts that 82,290 adults will receive a diagnosis for bladder cancer in 2023. Adstiladrin is a non-replicating vector-based gene therapy that activates interferon alpha 2b, causing the transcription and translation of genes that mediate antitumor effects. According to GlobalData, Adstiladrin is one of six therapies approved for the treatment of non-muscle invasive bladder cancer in the US , including two BCG vaccines . The therapy received approval based on positive Phase III trial (NCT02773849) results. GlobalData is the parent company of Pharmaceutical Technology. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva . Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. 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Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. Please check your email to download the Report.

Drug ApprovalPhase 3VaccineClinical ResultGene Therapy

20 Jun 2022

·www.prnewswire.com

Metastatic Castration-Sensitive Prostate Cancer Market to Reach Upto USD 5.5 billion by 2032 | DelveInsight

Metastatic Castration-Sensitive Prostate Cancer market dynamics is anticipated to witness a significant growth owing to the rising prevalence of prostate cancer cases due to the rapidly aging population growing awareness among people, market penetration in mCSPC due to label expansion, and entry of new emerging therapies. LAS VEGAS, June 20, 2022 /PRNewswire/ -- DelveInsight's Metastatic Castration-Sensitive Prostate Cancer Market Insights report proffers a detailed comprehension of the Metastatic Castration-Sensitive Prostate Cancer Market size by treatment, epidemiology, emerging therapies, market share of the individual therapies, current and forecasted Metastatic Castration-Sensitive Prostate Cancer Market size from 2019 to 2032 segmented into 7MM (the USA, EU5 (the UK, Italy, Spain, France, and Germany), and Japan). Some of the salient features from the Metastatic Castration-Sensitive Prostate Cancer Market Report: The Metastatic Castration-Sensitive Prostate Cancer market size in the 7MM was valued at USD 679.1 million in 2021 and is anticipated to grow during the study period (2019-2032). Key pharmaceutical Metastatic Castration-Sensitive Prostate Cancer companies such as Astellas Pharma, Pfizer, Janssen Pharmaceutical, Myovant Sciences, Takeda, Bayer, Merck Sharp & Dohme, Clovis Oncology, Bristol-Myers Squibb, Novartis Pharmaceuticals, Ferring Pharmaceuticals, Genentech, Exelixis, AstraZeneca, and others are reported to bring a significant shift in the Metastatic Castration-Sensitive Prostate Cancer Market. The Metastatic Castration-Sensitive Prostate Cancer emerging therapies that are expected to launch in the forecast period include Talazoparib, Nubeqa, Keytruda, Niraparib, Rubraca, Opdivo (nivolumab), Capivasertib, 177Lu-PSMA-617, Firmagon (Degarelix), Tecentriq (Atezolizumab), Cabometyx (Cabozantinib), and others. The United States accounts for the largest Metastatic Castration-Sensitive Prostate Cancer market size when compared to EU5 and Japan. In the United States, the Metastatic Castration-Sensitive Prostate Cancer market size was valued at USD 502.7 million in 2021 and is anticipated to rise during the forecast period. Earlier, most of the attention in the field of advanced prostate cancer was restricted to the research and development of drugs for patients with CRPC even though CSPC is burdened with poor prognosis and impaired quality of life. However, recent years have witnessed an expansion in the field of mCSPC which led to the FDA approval of a handful of drugs for this patient pool. Owing to these approvals, the market poses an opportunity for the upcoming drugs. Any medication, if approved, may capture a major share of the market due to a less competitive scenario. For further information on the market impact by therapies, download the Metastatic Castration-Sensitive Prostate Cancer Market sample @ Metastatic Castration-Sensitive Prostate Cancer Therapeutic Scenario Metastatic Castration-Sensitive Prostate Cancer Overview Prostate cancer is a type of malignancy that occurs in the prostate gland, which is a part of the male reproductive system. Prostate cancer is the 3rd most prevalent type of cancer in the US and the fourth most common worldwide. Approximately 1 in 9 men in the US will be diagnosed with prostate cancer at some point in their lives. Prostate cancer is the second leading cause of cancer death in American men, behind only lung cancer. Prostate cancer treatment includes mainly hormonal therapies (also known as androgen-deprivation therapy or ADT), chemotherapy, immunotherapy, radiation therapy, and surgery. For localized or locally advanced prostate cancer active surveillance, surgery, and radiation therapy are the 3 major treatment options. Patients who have never received ADT i.e. are sensitive to ADT are known as hormone-sensitive prostate cancer (HSPC) or castrate-sensitive prostate cancer (CSPC). For many years, the mCSPC market lacked treatment choices. While ADT produces early responses, progression is common, and men who are diagnosed with metastatic illness for the first time account for a high proportion of prostate cancer-related death. Due to advancements in clinical researcher for mCSPC, we now know that, in addition to ADT alone, adding docetaxel, abiraterone acetate, enzalutamide, or apalutamide to ADT early on increases overall survival considerably. Metastatic Castration-Sensitive Prostate Cancer Epidemiology Segmentation As per DelveInsight estimates, the total prevalent population of prostate cancer in the seven major markets was 7,726,394 cases in 2021. The cases in the 7MM are expected to increase during the study period, i.e., 2019–2032. As per DelveInsight estimates, the diagnosed cases of prostate cancer were the highest in the United States. The diagnosed cases of Prostate cancer in 2021 in the US were 1,327,642 cases. The Metastatic Castration-Sensitive Prostate Cancer Market report proffers epidemiological analysis for the study period 2019-2032 in the 7MM segmented into Total Prevalent Cases of Prostate Cancer Total Diagnosed Cases of Prostate Cancer Age-specific Cases of Prostate Cancer Total Diagnosed Cases of Prostate Cancer Total Metastatic Cases of Castration-Sensitive Prostate Cancer Total Treated Cases of Metastatic Castration-Sensitive Prostate Cancer Keen to learn how Metastatic Castration-Sensitive Prostate Cancer Epidemiological Trends are going to appear in 2032 for the 7 MM, Download @ Metastatic Castration-Sensitive Prostate Cancer Epidemiological Insights Metastatic Castration-Sensitive Prostate Cancer Market Outlook From the past few years, improvements in the field of prostate cancer have shown that treatments are more effective when used early. However, combination therapy has yet to be proven beneficial. In order to achieve that, it is necessary to possess a profound understanding of the Metastatic Castration-Sensitive Prostate Cancer market, and the associated unmet needs. Reflecting on these issues, the significance of dedicating resources to R&D is also imperative. Moreover, to achieve significant success in Metastatic Castration-Sensitive Prostate Cancer pricing, policies must be considered, because this further will help in the launch of a product that is truly attractive and appropriate to the market, where it is launched. All these factors help in building a strong product-market fit. Metastatic Castration-Sensitive Prostate Cancer treatment includes Zytiga (in combination with prednisone) manufactured by Janssen Pharmaceutical and was FDA approved in 2018. Another drug from Janssen that was approved in September 2019 was Erleada. And then, in December 2019, the FDA approved Xtandi for Metastatic Castration-Sensitive Prostate Cancer patients manufactured by the pharma giant - Pfizer. Lastly, in December 2020, Orgovyx by Myovant Sciences bagged FDA approval. The dynamics of the Metastatic Castration-Sensitive Prostate Cancer (mCSPC) market is anticipated to change in the coming years owing to the improvement in the research and development activities for efficient treatment options to be available in the market. The launch of emerging therapies is expected during the forecast period of 2022–2032. Potential Metastatic Castration-Sensitive Prostate Cancer therapies expected to launch are as follows Bayer (Nubeqa), Merck Sharp & Dohme, (Keytruda/), Pfizer (Talazoparib), Janssen (Niraparib), Clovis Oncology (Rubraca), Bristol-Myers Squibb (Opdivo), AstraZeneca (Capivasertib), Novartis (177Lu-PSMA-617), and others. Discover more about therapy set to grab substantial Metastatic Castration-Sensitive Prostate Cancer Market share @ Metastatic Castration-Sensitive Prostate Cancer Market Landscape Metastatic Castration-Sensitive Prostate Cancer Pipeline Therapies and Key Companies Nubeqa: Bayer Keytruda: Merck Sharp & Dohme Talazoparib: Pfizer Niraparib: Janssen Rubraca: Clovis Oncology Opdivo: Bristol-Myers Squibb Capivasertib: AstraZeneca 177Lu-PSMA-617: Novartis Tecentriq: Genentech Firmagon: Ferring Pharmaceuticals Cabometyx: Exelixis/ Bristol-Myers Squibb To know about more pipeline therapies covered in the report, visit @ Metastatic Castration-Sensitive Prostate Cancer Pipeline Analysis, Clinical Trials, and Emerging Therapies Metastatic Castration-Sensitive Prostate Cancer Market Dynamics Metastatic Castration-Sensitive Prostate Cancer market growth in the coming years is dependent on several factors such as increasing initiatives for R&D, a surge in investigation regarding prostate cancer treatment products. Also, innovation in drugs and developments in genomics and proteomics, as well as label expansion within prostate cancer, will directly boost the Metastatic Castration-Sensitive Prostate Cancer market. The increase in awareness regarding the disease is also considered an aspect driving the Metastatic Castration-Sensitive Prostate Cancer market growth. On the other hand, factors such as the emergence of generics, the need for novel therapies, and poor prognosis may serve as obstructions in the Metastatic Castration-Sensitive Prostate Cancer market growth. The c omplex issue of companion diagnostics, cost constraints observed and the i ssue of entry barriers might act as potential setbacks in the Metastatic Castration-Sensitive Prostate Cancer market. Know which therapy is expected to score the touchdown first @ Metastatic Castration-Sensitive Prostate Cancer Market Landscape and Forecast Scope of the Metastatic Castration-Sensitive Prostate Cancer Market Report Study Period: 2019-32 Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan] Key Metastatic Castration-Sensitive Prostate Cancer Companies: Astellas Pharma, Pfizer, Janssen Pharmaceutical, Myovant Sciences, Takeda, Bayer, Merck Sharp & Dohme, Clovis Oncology, Bristol-Myers Squibb, Novartis Pharmaceuticals, Ferring Pharmaceuticals, Genentech, Exelixis, AstraZeneca Key Metastatic Castration-Sensitive Prostate Cancer Pipeline Therapies: Talazoparib, Nubeqa, Keytruda, Niraparib, Rubraca, Opdivo (nivolumab), Capivasertib, 177Lu-PSMA-617, Firmagon (Degarelix), Tecentriq (Atezolizumab), Cabometyx (Cabozantinib) Metastatic Castration-Sensitive Prostate Cancer Therapeutic Assessment: Metastatic Castration-Sensitive Prostate Cancer current marketed and emerging therapies Metastatic Castration-Sensitive Prostate Cancer Market Dynamics: Metastatic Castration-Sensitive Prostate Cancer Market drivers and barriers Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies Unmet Needs KOL's views Analyst's views Metastatic Castration-Sensitive Prostate Cancer Market Access and Reimbursement Request for a Webex demo of the report @ Metastatic Castration-Sensitive Prostate Cancer Therapeutics Market Table of Contents Get in touch with our Business executive @ Metastatic Castration-Sensitive Prostate Cancer Regulatory and Patent Analysis Related Reports Prostate Cancer Market DelveInsight's "Prostate Cancer Market Insights, Epidemiology, and Market Forecast-2030" report delivers an in-depth understanding of Prostate cancer, emerging drugs, and key companies involved like Bayer Health Care, Amgen, Janssen Pharmaceutical, Sanofi, AstraZeneca/ Merck Sharp & Dohme, Bristol-Myers Squibb, Novartis, Hoffmann-La Roche, Pfizer, Clovis Oncology, Regeneron Pharmaceuticals, Suzhou Kintor Pharmaceutical, Eli Lilly and Company, and others. CAR-T Pipeline Insights DelveInsight's, "CAR-T – Pipeline Insights, 2021," report provides comprehensive insights about 250+ companies and 250+ pipeline drugs in the CAR-T pipeline landscape. It covers the pipeline drug profiles, including clinical and non-clinical stage products, key companies including, AbbVie Inc, Adaptimmune Therapeutics PLC, Amgen, Inc, Celgene, DiaCarta, Inc, Endocyte, Inc, F1 Oncology, Inc, Fate Therapeutics Inc, Gilead, Humanigen, Inc, Immune Therapeutics, Inc, Intrexon, Corp, Juno Therapeutics, Inc, Kite Pharma, Inc, Lion TCR Pte Ltd, MaxCyte, Inc, Mesoblast, Ltd. and others. Acute Myeloid Leukemia Pipeline DelveInsight's, "Acute Myeloid Leukemia (AML) - Pipeline Insight, 2021," report provides comprehensive insights about 100+ companies and 100+ pipeline drugs in Acute Myeloid Leukemia (AML) pipeline landscape. It covers the pipeline drug profiles, including clinical and non-clinical stage products, key companies including BioSight, GlycoMimetics, Novartis, Takeda, Menarini Group, ImmunoGen, Kartos Therapeutics, Plexxikon, Shijiazhuang Yiling Pharmaceutical, JW Pharmaceutical, Hanmi Pharmaceutical, GEMoaB Monoclonals, and several others. Non-muscle Invasive Bladder Cancer Market DelveInsight's 'Non-muscle Invasive Bladder Cancer (NMIBC)—Market Insights, Epidemiology and Market Forecast–2030' report deliver an in-depth understanding of the NMIBC, historical and forecasted epidemiology as well as the NMIBC market trends, market drivers, market barriers and key companies involved such as FKD Therapies Oy, Ferring Pharmaceuticals, Merck, Viventia Bio, Sesen Bio, CG Oncology, ImmunityBio, Altor Biosciences, Theralase, and many others. Checkpoint Inhibitor Refractory Cancer Market DelveInsight's 'Checkpoint Inhibitor Refractory Cancer—Market Insights, Epidemiology, and Market Forecast—2030' report deliver an in-depth understanding of the Checkpoint Inhibitor Refractory Cancer, historical and forecasted epidemiology, market drivers, market barriers, unmet medical needs, and key companies including Bristol-Myers Squibb, AstraZeneca, Merck, Genentech/Hoffmann-La Roche, Regeneron Pharmaceuticals, Merck KGaA, and Pfizer, Bristol-Myers Squibb, Janssen Research and Development, LLC, Exicure, Inc., Evelo Biosciences, Inc./Merck Sharp & Dohme Corp, Eisai, Kartos Therapeutics, Exelixis, Immunity Bio, and many others. Cervical Cancer Market DelveInsight's 'Cervical Cancer –Market Insights, Epidemiology, and Market Forecast-2030' report delivers an in-depth understanding of the disease, historical, and forecasted epidemiology, current treatment practices, emerging drugs like Cemiplimab, Durvalumab, Tisotumab vedotin, and key companies involved like Genentech/Roche, Iovance Biotherapeutics, Advaxis, Agenus, Akeso Biopharma, Altor BioScience, Amgen/Allergan, AstraZeneca, Avastin Biosimilars, and others Intratumoral Cancer Therapies Market DelveInsight's 'Intratumoral Cancer Therapies - Market Insights, Epidemiology and Market Forecast—2030' report delivers an in-depth understanding of the Intratumoral Cancer Therapies, market drivers, market barriers, unmet medical needs, and key companies involved like Amgen, Idera Pharmaceuticals, Philogen, Oncolys BioPharma, Highlight Therapeutics, Takara Bio, NanOlogy, Istari Oncology, Moderna Therapeutics, Intensity Therapeutics, and several others. Browse Through Our Blog Posts Showstoppers in Gastric Cancers - ASCO 2021 Intratumoral Cancer Therapy : A Potential Weapon To Fight the Battle Against Cancer Metastatic HER2-Positive Breast Cancer Infographic Pitfalls of Current Osteosarcoma Treatment Approaches About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Connect With Us at LinkedIn | Facebook | Twitter Contact Us Shruti Thakur [email protected] +1(919)321-6187 SOURCE DelveInsight Business Research, LLP

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Approved

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Indication	Country/Location	Organization	Date
Castration-sensitive prostate cancer	CH	Ferring Arzneimittel Gmbh	12 Feb 2010
Hormone-dependent prostate cancer	EU	Ferring Pharmaceuticals A/S	17 Feb 2009
Hormone-dependent prostate cancer	IS	Ferring Pharmaceuticals A/S	17 Feb 2009
Hormone-dependent prostate cancer	LI	Ferring Pharmaceuticals A/S	17 Feb 2009
Hormone-dependent prostate cancer	NO	Ferring Pharmaceuticals A/S	17 Feb 2009
Prostatic Cancer	US	Ferring Pharmaceuticals, Inc.	24 Dec 2008

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Prostate Carcinoma	Phase 3	US	Ferring Pharmaceuticals A/S	19 Apr 2016
Advanced Prostate Carcinoma	Phase 3	CA	Ferring Pharmaceuticals A/S	19 Apr 2016
Advanced Prostate Carcinoma	Phase 3	CZ	Ferring Pharmaceuticals A/S	19 Apr 2016
Advanced Prostate Carcinoma	Phase 3	FI	Ferring Pharmaceuticals A/S	19 Apr 2016
Advanced Prostate Carcinoma	Phase 3	FR	Ferring Pharmaceuticals A/S	19 Apr 2016
Advanced Prostate Carcinoma	Phase 3	DE	Ferring Pharmaceuticals A/S	19 Apr 2016
Advanced Prostate Carcinoma	Phase 3	GR	Ferring Pharmaceuticals A/S	19 Apr 2016
Advanced Prostate Carcinoma	Phase 3	PL	Ferring Pharmaceuticals A/S	19 Apr 2016
Advanced Prostate Carcinoma	Phase 3	RU	Ferring Pharmaceuticals A/S	19 Apr 2016
Advanced Prostate Carcinoma	Phase 3	SK	Ferring Pharmaceuticals A/S	19 Apr 2016

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Phase

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03056638 (CTgov)	Phase 3	Intermediate Atypical Prostate Carcinoma	56	stereotactic body radiosurgery (SBRT)+Degarelix (Degarelix in Conjunction With Stereotactic Body Radiosurgery)	kljlbuiwzq(wkornqdloz) = cumflxtadd cxkrpmzcbz (hghhrfgtfa, ivstjltkhx - qxedytkjvp) View more	-	28 Aug 2024
				stereotactic body radiosurgery (SBRT) (Stereotactic Body Radiosurgery (SBRT))	kljlbuiwzq(wkornqdloz) = sqgpvnbvrn cxkrpmzcbz (hghhrfgtfa, bncjkloiyp - ukzlnvjcek) View more
NCT02663908 (PRONOUNCE, CTgov)	Phase 3	Cardiovascular Diseases \| Advanced Prostate Carcinoma	545	Degarelix (Degarelix 240 mg/80 mg)	rscgjbcpfo(qukamrkhyr) = bnjjydwjme owtngvmqmj (uxdbelqfey, uxbuhmciud - dgkqfiakzo) View more	-	29 Jun 2022
				Leuprolide (Leuprolide 22.5 mg)	rscgjbcpfo(qukamrkhyr) = zmhiqufbjc owtngvmqmj (uxdbelqfey, zzvuhlcymz - gjnjeivche) View more
NCT04397718 (HITCH, CTgov)	Phase 2	COVID-19	96	Saline (Placebo + BSC)	lclnvmnewj(xgetetfqgf) = ehlozqbshy qyfkswdoof (xbagiskajr, apjzrijmbo - bhpuhzadkb) View more	-	06 Jun 2022
				Degarelix (Degarelix + BSC)	lclnvmnewj(xgetetfqgf) = jttoounchs qyfkswdoof (xbagiskajr, lzuxjxkquw - ipcbiqknau) View more
DUO (ASCO_GU2022)	Not Applicable	Prostatic Cancer	124	Degarelix	qtootivmgv(fuoudtrqfm) = 42 adverse events (AEs) were reported in 22 patients: degarelix-related AEs were reported in 4.4% of patients ategxapapt (tdivnufpyc )	-	16 Feb 2022
NCT01751451 (CTgov)	Phase 2	Prostatic Cancer	124	Abiraterone acetate (Abiraterone Acetate)	zxbdahqezj(bgjeouvhom) = ytqucmpykl jwovykrojc (ailqomibjy, cdizwidfaq - iimafvalii) View more	-	19 Nov 2021
				Abiraterone acetate plus degarelix (Abiraterone Acetate and Degarelix)	zxbdahqezj(bgjeouvhom) = qolktlnyfc jwovykrojc (ailqomibjy, pmgbpyhbmh - xjjblgeomh) View more
NCT02663908 (PRONOUNCE, Pubmed \| J Am Coll Cardiol) Manual	Phase 3	Prostatic Cancer	545	Degarelix	wzxnzpglpx(yavoumlupo) = ytaazaqfxi gawaugukvj (xnerbrivoz )	Similar	19 Oct 2021
				Leuprolide	wzxnzpglpx(yavoumlupo) = lqwoptrrya gawaugukvj (xnerbrivoz )
NCT00884273 \| NCT00946920 \| NCT02799706 \| NCT02475057 \| NCT01744366 \| NCT00833248 \| NCT01964170 \| NCT04182594 \| NCT00928434 \| NCT02663908 \| NCT00295750 \| NCT00831233 \| NCT01674270 \| NCT01542021 \| NCT00451958 \| NCT02234089 (Pubmed)	Not Applicable	Castration-Resistant Prostatic Cancer	11	Degarelix	vsrrvtijwq(ynwmfoegyk): RR = 0.8 (95% CI, 0.62 - 1.05) View more	-	05 Aug 2021
				Standard androgen suppression therapy
NCT03069937 (ASCO_GU2021) Manual	Phase 2	Metastatic Prostate Carcinoma First line	50	docetaxel+degarelix	ogulncfdho(luptbbfhxd) = oiqrgwqcmj rdnkvjregs (itpfmkiaus ) View more	Positive	02 Mar 2021
NCT02005887 (TREND, CTgov)	Phase 2	Invasive Mammary Carcinoma	51	Letrozol+Triptorelin (Arm A: Triptorelin + Letrozol)	ntcpoyqaxs(fgldmoorxm) = bsvtmwbpmz cxbrxxgxmg (yusicayeny, ikdjzgeuvr - nnrlgnjwno) View more	-	29 May 2019
				Letrozol+Degarelix (Arm B: Degarelix + Letrozol)	ntcpoyqaxs(fgldmoorxm) = elwladlhtx cxbrxxgxmg (yusicayeny, qopkzwxeew - iwyetbyeje) View more
NCT02489357 (CTgov)	Not Applicable	Metastatic Prostate Carcinoma	12	Cryosurgery+Degarelix+pembrolizumab	sleqlbplxq(trmovwnvoy) = ixovyeznvv thcbbmuxzy (ynaygjjqjy, nbwalbwtsm - zfuxbpwrcg) View more	-	03 Apr 2019

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