AstraZeneca's Lynparza Supplemental New Drug Application Granted Priority Review by FDA
16 Agosto 2022 - 8:50AM
Dow Jones News
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
anthony.orunagoriainoff@dowjones.com
(END) Dow Jones Newswires
August 16, 2022 02:35 ET (06:35 GMT)
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