1. Pink Sheet
  2. >>Regulatory Trackers

Biomarker-Restricted Indication Urged For AstraZeneca’s Lynparza In First-Line Prostate Cancer

 
• By Sue Sutter

Eleven of 13 members of the Oncologic Drugs Advisory Committee favor limiting olaparib’s use with abiraterone in metastatic castration-resistant prostate cancer to patients with tumors that carry the BRCA mutation, a subgroup that represented only 11% of the patients in the PROpel study.

Big and small
AstraZeneca sought a broad indication for olaparib in mCRPC but appears likely to nab approval for a much smaller population. • Source: Shutterstock

AstraZeneca PLC’s Lynparza (olaparib) appears headed for a restricted indication in first-line, metastatic castration-resistant prostate cancer (mCRPC) after a US Food and Drug Administration advisory committee voted overwhelmingly on 28 April to recommend limiting the PARP-inhibitor to patients whose tumors carry the BRCA mutation.

Eleven of 13 members of the Oncologic Drugs Advisory Committee favored an indication restricted by BRCA mutation status – the...

More from US FDA Performance Tracker

More from Regulatory Trackers