The market report provides current treatment practices, emerging drugs, CRPC market share of the individual therapies, current and forecasted CRPC market size from 2017 to 2030 segmented by seven major markets.
The report also covers current CRPC treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate best of the opportunities and assesses underlying potential of the market.
The CRPC epidemiology division provides the insights about historical and current CRPC patient pool and forecasted trend for each seven major countries.
It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders.
This part of the report also provides the diagnosed patient pool and their trends along with assumptions undertaken.
The total cases of CRPC in the 7MM were found to be 265,891 in 2017 which is expected to grow during the study period, i.e., 2017-2030.
The disease epidemiology covered in the report provides historical as well as forecasted CRPC epidemiology [segmented as Total Prevalent Cases of Prostate Cancer, Total Diagnosed Cases of Prostate Cancer, Age-specific Cases of Prostate Cancer, Total Diagnosed Cases of Prostate Cancer by Clinical Stages, Total Non-metastatic and Metastatic Cases of CRPC, and Total Treated Cases of Non-metastatic and Metastatic CRPC] scenario of CRPC in the 7MM covering United States, EU5 countries (Germany, France, Italy, Spain, and United Kingdom), and Japan from 2017 to 2030.
Drug chapter segment of the CRPC report encloses the detailed analysis of CRPC marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs.
It also helps to understand the CRPC clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.
Erleada (apalutamide): Janssen Pharmaceuticals
Erleada (apalutamide) is a next-generation oral androgen receptor (AR) inhibitor that blocks the androgen signaling pathway in prostate cancer cells.
It is indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). It is taken orally, once daily, with or without food.
Erleada inhibits the growth of cancer cells in three ways: by preventing the binding of androgen to the AR; by stopping the AR from entering the cancer cells; and by preventing the AR from binding to the DNA of the cancer cell.
- In February 2018, Erleada received approval from the United States Food and Drug Administration (US FDA) for the treatment of patients with nmCRPC.
- In January 2019, the European Commission (EC) has granted marketing authorization for Erleada next generation oral androgen receptor inhibitor for the treatment of adult patients with nmCRPC who are at high risk of developing metastatic disease.
- In March 2019, Janssen obtained the Ministry of Health, Labour and Welfare (MHLW) approval of Erleada (apalutamide) 60mg tablet for the treatment for adults with castration-resistant prostate cancer without distant metastases.
- In August 2013, Johnson & Johnson completed acquisition of Aragon Pharmaceuticals, Inc., a privately-held pharmaceutical company focused on drugs to treat hormonally-driven cancers.
Xtandi (Enzalutamide): Astellas Pharma/Pfizer
It is an orally bioavailable, organic, non-steroidal small molecule targeting the androgen receptor with potential antineoplastic activity. Enzalutamide inhibits the activity of prostate cancer cell ARs, which may result in a reduction in prostate cancer cell proliferation and, correspondingly, a reduction in the serum prostate specific antigen (PSA) level.
AR over-expression in prostate cancer represents a key mechanism associated with prostate cancer hormone resistance.
In September 2014, the US FDA approved a new indication for the use of Xtandi capsules to treat patients with metastatic CRPC.
The FDA initially approved Xtandi, an oral, once daily androgen receptor inhibitor, in August 2012 for use in patients with metastatic CRPC who previously received docetaxel (chemotherapy).
In October 2009, Medivation, which is now part of Pfizer and Astellas entered into a global agreement to jointly develop and commercialize enzalutamide.
Nubeqa (Darolutamide/ODM-201): Bayer HealthCare/Orion Corporation
Nubeqa is an androgen receptor inhibitor with a distinct chemical structure that competitively inhibits androgen binding, AR nuclear translocation, and AR-mediated transcription.
Nubeqa is approved for the treatment of patients with nmCRPC. Nubeqa is supplied as film-coated tablets containing 300 mg of darolutamide for oral use. In July 2019, the US FDA approved darolutamide, for nmCRPC. Approval was based on ARAMIS (NCT02200614), a multicenter, double-blind, placebo-controlled clinical trial in 1,509 patients with nmCRPC. Nubeqa is also approved in European Union as well as in Japan.
Jevtana (Cabazitaxel): Sanofi
Jevtana (cabazitaxel) injection is an antineoplastic agent belonging to the taxane class that is for intravenous use. It is prepared by semi-synthesis with a precursor extracted from yew needles.
It is a microtubule inhibitor indicated in combination with prednisone for treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen.
This product is marketed in US, Europe, Japan as well as, over 75 countries. Jevtana had also received the fast-track designation by the US FDA for metastatic prostate cancer.
Lynparza (Olaparib): AstraZeneca/Merck Sharp & Dohme
Lynparza (olaparib) is first and best-in-class oral poly ADP-ribose polymerase (PARP) inhibitor, and the -first targeted treatment to block DDR in tumoursharbouring a deficiency in homologous recombination repair (HRR), such as mutations in BRCA1 and/or BRCA2. Astrazeneca have global strategic oncology collaboration with Merck to co-develop and co-commercialize Lynparza.
Recently in January 2020, the US FDA accepted the supplemental New Drug Application for Lynparza (olaparib) and granted Priority Review in the US for patients with mCRPC and deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene mutations, which have progressed following prior treatment with a new hormonal agent.
A Prescription Drug User Fee Act (PDUFA) date is set for the second quarter of 2020. The priority review is based on the results from the Phase III PROfound trial, which were presented during the Presidential Symposium at the 2019 European Society of Medical Oncology congress.
Currently, it is also in phase III trial in combination with abiraterone for the treatment of patients with first-line therapy in men with mCRPC. It was also evident by AstraZeneca pipeline that the filing of Lynparza was also accepted in Europe and Japan for patients with mCRPC and deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene mutations, which have progressed following prior treatment with a new hormonal agent.
Rubraca (Rucaparib): Clovis Oncology
Clovis Oncology is investigating one of their lead candidates named Rubraca (Rucaparib) for various cancer indications. It is an oral, small-molecule inhibitor of PARP1, PARP2 and PARP3 being developed in Prostate Cancer, and Ovarian Cancer as well as several additional solid tumor indications.
The US Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) for Rubraca and granted priority review status to the application with a Prescription Drug User Fee Act (PDUFA) date of May 15, 2020.
Clovis submitted the NDA submission for Rucaparib as monotherapy treatment of adult patients with BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer in November 2019.
Niraparib: Janssen Research & Development
Niraparib is an orally available, highly selective poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor, with potent activity against PARP-1 and PARP-2 deoxyribonucleic acid (DNA)-repair polymerases.
Niraparib is currently investigated by Janssen Research & Development. However, Niraparib is currently marketed as ZEJULA by TESARO (an oncology-focused business within GSK), devoted to providing transformative therapies to people facing cancer. At present, Niraparib is being evaluated in MAGNITUDE, GALAHAD, and QUEST study.
Opdivo (nivolumab): Bristol-Myers Squibb
Opdivo (Nivolumab) by Bristol-Myers Squibb is a human immunoglobulin (Ig) G4 monoclonal antibody directed against the negative immunoregulatory human cell surface receptor PD-1, with immune checkpoint inhibitory and antineoplastic activities.
BMS is working on assessing the clinical activity seen with Opdivo in combination with docetaxel in male patients with metastatic castration-resistant prostate cancer.
This drug is currently in phase III trial in combination with docetaxel for patients with metastatic castration resistant prostate cancer who have progressed after second-generation hormonal manipulation.
Apart from this it is also in phase II trial in combination with Yervoy for patients with metastatic castration-resistant prostate cancer who have progressed after prior Docetaxel-containing regimen.
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