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US FDA to discuss AstraZeneca and Merck’s Lynparza cancer drug combo

ALN

AstraZeneca PLC and Merck & Co Inc said on Thursday that the US Food & Drug Administration will convene a meeting of the Oncologic Drugs Advisory Committee to discuss the supplemental new drug application for Lynparza in combination with abiraterone and prednisone or prednisolone.

The ODAC meeting is scheduled for April 28 and will discuss the Lynparza combination for the treatment of adults with metastatic castration-resistant prostate cancer.

The Lynparza combination is already approved in the EU and several other countries for the treatment of adults with metastatic castration-resistant prostate cancer, the pharmaceutical companies said.

Lynparza is being jointly developed and commercialised by AstraZeneca and Merck. In July 2017, the two companies announced a oncology collaboration to co-develop and co-commercialise Lynparza, a PARP inhibitor, and Koselugo, a mitogen-activated protein kinase inhibitor, for multiple cancers.

Shares in AstraZeneca closed 0.3% higher at 10,843.16 pence on Thursday in London. Merck shares were trading 0.2% higher at $106.91 on Thursday afternoon in New York.

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