AstraZeneca's Lynparza Supplemental New Drug Application Granted Priority Review by FDA

By Anthony O. Goriainoff

AstraZeneca PLC said Tuesday that its supplemental new drug application, or sNDA, for its cancer treatment, Lynparza in combination with abiraterone, has been granted a priority review by the U.S. Food and Drug Administration.

The Anglo-Swedish pharma giant said the priority review is for the treatment of adult patients with metastatic castration-resistant prostate cancer.

The U.S. Food and Drug Administration grants priority review status to medicinal applications that, if approved, would offer significant improvements over available options.

AstraZeneca said the sNDA was based on results from the PROpel Phase 3 trial, which showed that Lynparza, when combined with abiraterone, reduced the risk of disease progression or death by 34% versus abiraterone alone.

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

(END) Dow Jones Newswires

08-16-22 0235ET