Phase III Data AFFIRM Safety As Well As Survival For MDV3100
This article was originally published in Pharmaceutical Approvals Monthly
Medivation’s MDV3100 demonstrates a favorable safety profile and hits secondary efficacy endpoints in the AFFIRM study. Drug does not need to be given with prednisone, and could give J&J’s recently launched Zytiga a run for its money.
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Medivation and Astellas have submitted their castration-resistant prostate cancer drug enzalutamide to FDA and hope to gain priority review for the long-anticipated therapy.
Johnson & Johnson’s prostate cancer drug Zytiga is off to a brilliant launch. Payors are covering it with relatively few restrictions, medical oncologists are using it in advanced patients, and it has streaked ahead of its direct competitor Jevtana, a second-generation taxane, in part by grabbing new patient share from the same post-docetaxel population.
Phase III data for Medivation's MDV3100 suggest the prostate cancer drug stands to unseat J&J’s market leader Zytiga in many of the disease settings.