AstraZeneca: Lynparza Gets FDA Priority Review -- Update
November 30 2021 - 06:00AM
Dow Jones News
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 colin.kellaher@wsj.com and Anthony O.
Goriainoff at anthony.orunagoriainoff@dowjones.com
(END) Dow Jones Newswires
November 30, 2021 06:45 ET (11:45 GMT)
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