FDA advisory committee votes against plan for broad use of prostate cancer drug
An FDA advisory committee on Friday voted against AstraZeneca and Merck’s bid to expand its Lynparza label to all adult patients with metastatic castration-resistant prostate cancer (mCRPC).
The drug, a PARP inhibitor also known as olaparib, was approved in 2020 for mCRPC patients who have a genetic mutation called homologous recombination repair (HRR). The latest application sought to allow Lynparza to be used in patients with or without HRR mutations in combination with abiraterone (J&J’s branded Zytiga) and prednisone or prednisolone alone.
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