MDV3100 is an androgen receptor antagonist drug developed with promise for hormone refractory prostate cancer, and it is in Phase 3 clinical trials and for breast cancer. MDV3100 has binds five times stronger to the androgen receptor (AR) than Casodex, a popular hormonal drug that is currently used. It also interacts with the cancer cels in other ways.
Median time to radiographic progression in a phase II study was 56 weeks for chemo-naive patients and 25 weeks for patients previously treated with chemotherapy. A phase III trial AFFIRM (NCT00974311), in men with metastatic castration-resistant prostate cancer (CRPC) who had progressed after treatment with docetaxel-based chemotherapy, was stopped in November 2011 after a planned interim analysis showed a 37% reduction in the risk for death with MDV3100 over.Based on this the drug was approved under teh name Xtandin in mid 2012.
Another phase III trial, PREVAIL(NCT012129 is ongoing in patients who are chemo naive. There is also a phase II trial began in March 2011 comparing MDV3100 with Casodex in patients who have progressed while on LHRH analogue therapy (e,g., leuprorelin) or surgical castration.
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