FDA approves use of enzalutamide in chemotherapy-naive mCRPC

This afternoon the U.S. Food & Drug Administration approved enzalutamide (Xtandi) as a treatment for patients with chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC) based on the results of the PREVAIL trial. … READ MORE …

FDA approves enzalutamide for treatment of post-chemotherapy mCRPC

Demonstrating (once again) that the U.S. Food and Drug Administration (FDA) moves with alacrity when presented with good data to support the approval of important new therapeutic agents, the agency has today approved enzalutamide (to be known as Xtandi®) for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) previously treated with docetaxel-based chemotherapy. … READ MORE …

FDA sets “action date” of November 22 for MDV3100

According to a joint media release issued by Medivation and Astellas Pharma, the US Food & Drug Adminstration (FDA) has informed Medivation that the Prescription Drug User Fee Act (PDUFA) action date for the review of the new drug application (NDA) for enzalutamide (also known as MDV3100) will be November 22, 2012. … READ MORE …

FDA grants priority review for MDV3100 in mCRPC

According to a media release issued by Medivation, the U.S. Food and Drug Administration has accepted and granted priority review of the company’s new drug application for enzalutamide (a.k.a. MDV3100) as a treatment for men with metastatic, castration-resistant prostate cancer (mCRPC).

PREVAIL trial of MDV3100 now fully enrolled

According to information released today by Astellas Pharma and Medivation, the PREVAIL trial of MDV3100 (also now known as enzalutamide) in men with chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC) is fully enrolled. .. READ MORE …

Key presentations at ASCO today on advanced prostate cancer

The key prostate cancer presentations today at the annual meeting of the American Society of Clinical Oncology (ASCO) were all given at a morning session on high-risk and advanced prostate cancer. … READ MORE …

Two important new trials of enzalutamide and cabozantinib for patients with mCRPC

According to media releases from the relevant companies, two significant trials (of enzalutamide and of cabozantinib) are already or will soon be recruiting men with metastatic, castration-resistant prostate cancer (mCRPC). … READ MORE …