AstraZeneca: FDA grants priority review to Lynparza

(CercleFinance.com) - US health regulators have granted a priority review for AstraZeneca and Merck's Lynparza as a treatment for advanced ovarian cancer, potentially accelerating the treatment's route to market.


The US Food and Drug Administration (FDA) has accepted priority review for the use of Lynparza tablets as a maintenance treatment in patients with newly-diagnosed, BRCA-mutated (BRCAm) advanced ovarian cancer, the drugmakers said.

The decision concerns patients who were in complete or partial response following first-line standard platinum-based chemotherapy, they said.

A priority review takes six months - rather than the usual 12 months. In this case, a decision date has been scheduled for the first quarter of 2019.

Lynparza is being jointly developed and marketed by AstraZeneca and Merck.

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