Merck and AstraZeneca updates on US regulatory review of Lynparza for mCRPC
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Merck and AstraZeneca updates on US regulatory review of Lynparza for mCRPC

AstraZeneca and Merck are committed to working with the FDA to bring LYNPARZA in combination with abi/pred to patients diagnosed with mCRPC.

  • By IPP Bureau | March 03, 2023

AstraZeneca and Merck announced that the U.S. Food and Drug Administration (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.

The sNDA is based on the results of the Phase 3 PROpel trial. Results from PROpel, including the primary endpoint of radiographic progression-free survival (rPFS), were first presented at the 2022 American Society of Clinical Oncology (ASCO) Genitourinary Cancers (GU) Symposium and subsequently published in NEJM Evidence. Results from the final pre-specified overall survival (OS) analysis were presented at ASCO GU 2023.

LYNPARZAin combination with abi/pred is approved in the European Union and several other countries for the treatment of adult patients with mCRPC, based on the PROpel trial.

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