More Competition In Prostate Cancer? Medivation’s Enzalutamide Now With FDA
This article was originally published in The Pink Sheet Daily
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.
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The most recent events in the fast-evolving castration-resistant prostate cancer field illustrate how the major advances in therapy for patients who failed chemotherapy are now spreading to the larger population of CRPC patients receiving first-line therapy for metastatic disease. The upcoming year should see Phase III results from candidates ranging from a kinase inhibitor to an antisense agent.
A number of topical issues will be investigated by the HHS Office of Inspector General, according to its work plan for fiscal year 2013. Pharma industry issues are concentrated in the Medicare and Medicaid space.
Astellas has tried to build oncology knowhow in the past six years, and while licensed compounds approach approval, Phase II in-house compounds may show whether it can be a global leader.