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AstraZeneca-Merck's Lynparza gets US FDA priority review in prostate cancer


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AstraZeneca-Merck's Lynparza gets US FDA priority review in prostate cancer

AstraZeneca PLC and Merck & Co. Inc.'s Lynparza was granted priority review in the U.S. to treat patients with a certain type of prostate cancer.

The U.S. Food and Drug Administration is expected to make a decision on the companies' medicine in the second quarter of 2020.

The companies filed a supplemental new drug application for Lynparza, or olaparib, to treat patients with castration-resistant prostate cancer who did not improve following treatment with a new hormonal agent.

The regulator's decision is based on a phase 3 trial called PROfound which found Lynparza was better than Johnson & Johnson's Zytiga, or abiraterone, and Astellas Pharma Inc. and Pfizer Inc.'s Xtandi, or enzalutamide, in treating prostate cancer patients with mutations in their BRCA1/2 or ATM genes.

Lynparza belongs to a class of medicines known as PARP inhibitors, which work by preventing the PARP protein in cancer cells from repairing their damaged DNA — causing them to die instead.

U.K's AstraZeneca and Kenilworth, N.J.-based Merck are developing Lynparza under an $8.5 billion collaboration agreement signed in 2017.

The drug is already approved as a maintenance therapy for certain ovarian cancer patients in the EU, U.S. and Japan. In the U.S., Lynparza is also approved to treat patients with BRCA-mutated breast cancer.