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 …
Filed under: Drugs in development, Management, Treatment | Tagged: enzalutamide, MDV3100 | 6 Comments »
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 …
Filed under: Drugs in development | Tagged: approval, enzalutamide, MDV3100 | 1 Comment »
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).
Filed under: Drugs in development, Management, Treatment | Tagged: enzalutamide, MDV3100 | 2 Comments »
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 …
Filed under: Drugs in development, Living with Prostate Cancer, Management, Treatment | Tagged: abiraterone, enzalutamide, MDV3100 | 2 Comments »
According to the abstract of a paper to be presented at the upcoming meeting of the American Society for Clinical Oncology in Chicago at the beginning of June, 24 weeks of treatment with neoadjuvant abiraterone acetate + prednisone + an LHRH agonist appears to be able to eliminate visible risk of prostate cancer in post-surgical specimens in a small percentage of men diagnosed with high-risk disease. … READ MORE …
Filed under: Diagnosis, Drugs in development, Management, Risk, Treatment, Uncategorized | Tagged: abiraterone, dutasteride, enzalutamide, leuprolide, MDV3100, neoadjuvant, pre-surgical | 6 Comments »
An article just published in Cancer Research this week suggests that adding the investigational agent enzalutamide (MDV3100) to abiraterone acetate and prednisone in men being treated for metastatic, castration-resistant prostate cancer (mCRPC) may be able to further delay disease progression among men showing signs of progression after initial treatment with abiraterone acetate. … READ MORE …
Filed under: Drugs in development, Living with Prostate Cancer, Management, Treatment | Tagged: abiraterone, castration-resistant, enzalutamide, mCRPC, MDV3100 | 2 Comments »
Here is a question that is on the minds of many physicians and patients on Planet Prostate Cancer today: Can treatment with abiraterone acetate or similar agents replace the continuous and/or the intermittent first-line use of LHRH-agonist–induced medical castration in patients with high-risk and advanced forms of prostate cancer? … READ MORE …
Filed under: Drugs in development, Living with Prostate Cancer, Management, Treatment | Tagged: abiraterone, enzalutamide, LHRH agonist, MDV3100 | 8 Comments »
According to a media release issued by Medivation immediately prior to the annual meeting of the American Association for Cancer Research in Chicago (now wrapping up), the drug we have all known as MDV3100 for the past few years now has an approved “scientific” name: enzalutamide. … READ MORE …
Filed under: Drugs in development | Tagged: antiandrogen, enzalutamide, MDV3100 | 1 Comment »
According to a number of media reports today, Medivation’s investigational drug MDV3100 appears to have a relatively good safety profile, although five patients who received MDV3100 in the completed Phase III trial did have seizures. … READ MORE …
Filed under: Drugs in development, Management, Treatment | Tagged: efficacy, mCRPC, MDV3100, Phase III, safety | 6 Comments »
According to a Reuters report and a media release this morning, Medivation has announced that interim results of the Phase III AFFIRM trial showed a 4.8-month survival benefit for treatment with MDV3100 compared to a placebo in men with metastatic, castration-resistant prostate cancer after treatment with docetaxel-based chemotherapy. … READ MORE …
Filed under: Drugs in development, Management, Treatment | Tagged: AFFIRM, mCRPC, MDV3100, outcome | 2 Comments »
THE "NEW" PROSTATE CANCER INFOLINK 