Metastatic Castration-Sensitive Prostate Cancer Drug Chapters
Drug chapter segment of the mCSPC report encloses the detailed analysis of mCSPC marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the mCSPC 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.
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Metastatic Castration-Sensitive Prostate Cancer Marketed Drugs
Xtandi (Pfizer)
Xtandi is an orally bioavailable, organic, non-steroidal small molecule targeting the AR with potential antineoplastic activity. Through a mechanism that is reported to be different from other approved AR antagonists, 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 PSA level. AR over-expression in prostate cancer represents a key mechanism associated with prostate cancer hormone resistance. In December 2019, Pfizer and Astellas announced that the US FDA approved a sNDA for Xtandi for the treatment of patients with mCSPC. The approval is based on results from ARCHES, a randomized phase III study which evaluated 1,150 men with mCSPC and met its primary endpoint of rPFS. In April 2021, the company announced that the EC approved an additional indication for Xtandi for adult men with mHSPC. In May 2020, the company announced that the Japanese MHLW approved the drug for the treatment of prostate cancer patients with distant metastasis.
Erleada (Janssen Pharmaceutical)
Erleada (apalutamide) is a next-generation oral AR inhibitor that blocks the androgen signaling pathway in prostate cancer cells. It is indicated for the treatment of patients with nmCRPC and for the treatment of patients with 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 US FDA for the treatment of patients with nmCRPC. Later to that year, i.e., in September 2019, the US FDA approved Erleada for the treatment of patients with mCSPC. In January 2019, the EC granted marketing authorization for Erleada for the treatment of adult patients with nmCRPC who are at high risk of developing metastatic disease. In January 2020, the EC approved Erleada for use in combination with ADT for the treatment of adult men with mHSPC. In March 2019, Janssen obtained the MHLW approval of Erleada 60mg tablet for the treatment for adults with mCRPC. In May 2020, Nippon Shinyaku announced that Janssen Pharmaceutical which is the marketing authorization holder of the drug has obtained an expanded approval for the treatment of men with prostate cancer with distant metastases from the Ministry of Health, Labor and Welfare (MHLW).
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