Update provided on US Regulatory Review of LYNPARZA + Abiraterone in mCRPC patients
“FDA will convene a meeting of the Oncologic Drugs Advisory Committee (ODAC) to discuss the supplemental new drug application (sNDA) for use of LYNPARZA in combination with abiraterone and prednisone or prednisolone (abi/pred) for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC). The ODAC provides the FDA with independent, expert advice and recommendations on marketed and investigational medicines for use in the treatment of cancer. The FDA is not bound by the committee’s guidance but takes its advice into consideration. The ODAC Meeting is scheduled for April 28, 2023. AstraZeneca and Merck are committed to working with the FDA to bring LYNPARZA in combination with abi/pred to patients diagnosed with mCRPC.”
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