Tags: cancer | prostate | medication | astrazeneca | lynparza | brca | gene

FDA Panel Backs Restricted Use of Prostate Cancer Drug

'Diagnosis: Prostate Cancer' and some pills and stethoscope
(Dreamstime)

Monday, 01 May 2023 03:09 PM EDT

A panel of U.S. Food and Drug Administration advisers on Friday voted for the restricted use of British drugmaker AstraZeneca Plc's experimental treatment, jointly developed with Merck & Co, for a type of prostate cancer.

The FDA panel voted 11-1 with one abstention, in favor of Lynparza, in combination with other medications – abiraterone and prednisone or prednisolone – as a first-line treatment for a type of treatment-resistant prostate cancer in adult patients.

However, the panel recommended the approval to be limited only to patients whose tumors have a mutation in the BCRA genes, and advised against approval beyond this patient population.

Its recommendation comes after Lynparza and similar class of therapies suffered a series of safety setbacks as clinical data suggested that patients do not live as long as those given chemotherapy when given as a second-line therapy.

Lynparza belongs to a class of drugs called PARP inhibitors, which include Clovis Oncology's Rubraca and GSK Plc's Zejula.

They were withdrawn last year as second line of treatment for ovarian cancer patients after the FDA limited the use of PARP inhibitors and requested companies to pull the drug.

Friday's vote is based on a late-stage study, which showed Lynparza in combination significantly improved duration for which patients live without disease worsening when compared to the placebo in combination with abiraterone and prednisone/prednisolone.

Lynparza is already approved by the FDA to treat a type of breast cancer, ovarian cancer, as well as a different form of prostate cancer.

The FDA while making its final decision on the use of the drug usually follows the recommendations of its expert panel but is not obligated to do so.

© 2026 Thomson/Reuters. All rights reserved.


Health-News
A panel of U.S. Food and Drug Administration advisers on Friday voted for the restricted use of British drugmaker AstraZeneca Plc's experimental treatment, jointly developed with Merck & Co, for a type of prostate cancer. The FDA panel voted 11-1 with one abstention, in...
cancer, prostate, medication, astrazeneca, lynparza, brca, gene, fda, recommendation, restricted
275
2023-09-01
Monday, 01 May 2023 03:09 PM
Newsmax Media, Inc.

Sign up for Newsmax’s Daily Newsletter

Receive breaking news and original analysis - sent right to your inbox.

(Optional for Local News)
Privacy: We never share your email address.
Join the Newsmax Community
Read and Post Comments
Please review Community Guidelines before posting a comment.
 
Find Your Condition
Get Newsmax Text Alerts
TOP

The information presented on this website is not intended as specific medical advice and is not a substitute for professional medical treatment or diagnosis. Read Newsmax Terms and Conditions of Service.

Newsmax, Moneynews, Newsmax Health, and Independent. American. are registered trademarks of Newsmax Media, Inc. Newsmax TV, and Newsmax World are trademarks of Newsmax Media, Inc.

NEWSMAX.COM
© Newsmax Media, Inc.
All Rights Reserved
NEWSMAX.COM
© Newsmax Media, Inc.
All Rights Reserved