AstraZeneca: Lynparza Gets FDA Priority Review -- Update

By Colin Kellaher and Anthony O. Goriainoff

AstraZeneca PLC on Tuesday said the U.S. Food and Drug Administration granted priority review to an application for expanded use of Lynparza, the cancer drug it developed with Merck & Co., in BRCA-mutated HER2-negative high-risk early breast cancer.

The Anglo-Swedish pharmaceutical company said the application covers the adjuvant treatment of patients who have already been treated with chemotherapy either before or after surgery.

AstraZeneca said the application is based on results from a Phase 3 study in which Lynparza showed a statistically significant improvement in invasive disease-free survival.

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period. AstraZeneca said the agency set a target action during the first quarter of 2022 for the application.

AstraZeneca and Merck, based in Kenilworth, N.J., in 2017 formed a collaboration to co-develop and co-commercialize Lynparza for multiple cancer types. The drug has been approved in numerous countries for use in a range of cancer indications, with regulatory reviews underway in several countries for ovarian, breast, pancreatic and prostate cancers.

Write to Colin Kellaher at [e-mail] and Anthony O. Goriainoff at [e-mail]

(END) Dow Jones Newswires

November 30, 2021 06:45 ET (11:45 GMT)

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