Regulatory Round-Up: Drug Review Profiles From 2012
This article was originally published in Pharmaceutical Approvals Monthly
Each month, Pharmaceutical Approvals Monthly analyzes the FDA review process for a recent approval based on the NDA or BLA review documents. A detailed chronology of product development and listing of key reviewers accompany each profile.
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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.
Medivation/Astellas’ enzalutamide capped off an extraordinary three-year run in advanced castration-resistant prostate cancer therapy, with three successive NMEs each offering a greater survival advantage than the last. That accelerated evolution of new therapies created a complex context for FDA reviews.
The review division and CDER senior staff supported approval of Genentech’s highly teratogenic, basal cell carcinoma treatment vismodegib without a Risk Evaluation and Mitigation Strategy, but the Division of Risk Management believed a communications plan should be carried out under a REMS for the first-in-class Hedgehog pathway inhibitor.