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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...

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More from US FDA Performance Tracker

Complete Response Letter Trio Raises Prospect Of Tidal Shift In Regenerative Medicine Regulation

 
• By Bridget Silverman

Replimune's RP1 oncolytic immunotherapy became the third regenerative medicine to receive an FDA complete response letter this month as the agency appears to re-visit previous agreements about accelerated approval.

US FDA’s Second Half 2025 User Fee Goals Swing Toward Respiratory Disease

 
• By Bridget Silverman

The 43 novel agents with user fee goal dates in the remainder of 2025 have fewer oncologics and infectious disease drugs than the first half of the year.

Slowdown: US FDA’s 2025 Novel Approvals Are On Below-Average Pace

 
• By Bridget Silverman

US FDA's 25 novel approvals in 2025 fell short of the agency's five-year average count, driven by a drop in drugs center approvals; 45 user fee goals remain in second half of year.

US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 
• By Bridget Silverman

The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.

More from Regulatory Trackers

US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 
• By Bridget Silverman

The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.

America Next: Most Novel Agents With July Goal Dates Have Been Approved Overseas

 
• By Bridget Silverman

The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the US

EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.