FDA approves enzalutamide for treatment of post-chemotherapy mCRPC

Posted on August 31, 2012 by Sitemaster

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 …

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FDA sets “action date” of November 22 for MDV3100

Posted on August 6, 2012 by Sitemaster

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 …

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FDA grants priority review for MDV3100 in mCRPC

Posted on July 24, 2012 by Sitemaster

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).

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PREVAIL trial of MDV3100 now fully enrolled

Posted on June 6, 2012 by Sitemaster

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 …

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Key presentations at ASCO today on advanced prostate cancer

Posted on June 2, 2012 by Sitemaster

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 …

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

Posted on May 30, 2012 by Sitemaster

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 …

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Abiraterone acetate may help to eliminate cancer prior to surgery in some men with high-risk, localized disease

Posted on May 17, 2012 by Sitemaster

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 …

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Is combining abiraterone acetate with MDV3100 going to be clinically beneficial in mCRPC?

Posted on May 2, 2012 by Sitemaster

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 …

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Can the new hormone therapies actually replace the older ones?

Posted on April 17, 2012 by Sitemaster

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 …

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MDV3100 gets a proper scientific name

Posted on April 4, 2012 by Sitemaster

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 …

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Another step in the projected marketing battle: abiraterone vs. MDV3100

Posted on March 23, 2012 by Sitemaster

We have become aware of what appears to be the next step in the projected marketing battle between MDV3100 and abiraterone acetate for prominence as the “better” form of androgen suppressive agent in men with metastatic, castration-resistant prostate cancer (mCRPC). … READ MORE …

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Side effect profile of MDV3100 appears highly promising in mCRPC

Posted on February 1, 2012 by Sitemaster

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 …

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Full results of the AFFIRM trial at GU Oncology meeting next month

Posted on January 9, 2012 by Sitemaster

According to a joint media release from Medivation and Astellas Pharma earlier today, the full results of the Phase III AFFIRM trial — of MDV3100 in men with metastatic castration-resistant prostate cancer (mCRPC) who have received docetaxel chemotherapy — will be presented at the ASCO Genitourinary Oncology meeting on February 2, 2012. … READ MORE …

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MDV3100 shows survival benefit in Phase III AFFIRM trial

Posted on November 3, 2011 by Sitemaster

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 …

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MDV3100 vs. abiratetone acetate: the analysts’ perspectives

Posted on May 19, 2011 by Sitemaster

Some readers may be interested in in reading a commentary by John Carroll on the FierceBiotech web site, where he discusses whether MDV3100 is going to be able to “match up” to abiraterone acetate — always assuming that MDV3100 can also show a survival benefit in men with metastatic, castration-resistant prostate cancer (mCRPC). … READ MORE …

Filed under: Drugs in development, Living with Prostate Cancer, Management, Treatment | Tagged: , , | 2 Comments »

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