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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 small subgroup of patients for which efficacy appeared strongest in...

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More from US FDA Performance Tracker

Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
• By Bridget Silverman

Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.

Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC Bet

 
• By Bridget Silverman

The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.

AMR-Targeting Drug Secures EMA PRIME Designation

 
• By Neena Brizmohun

Antabio’s next-generation, broad-spectrum antibacterial, MEM-ANT3310, has made it onto the European Medicines Agency’s priority medicines scheme. The company says its product is designed to make a significant impact on the growing problem of antimicrobial resistance.

US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
• By Bridget Silverman

Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.

More from Regulatory Trackers

Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC Bet

 
• By Bridget Silverman

The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.

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.

AMR-Targeting Drug Secures EMA PRIME Designation

 
• By Neena Brizmohun

Antabio’s next-generation, broad-spectrum antibacterial, MEM-ANT3310, has made it onto the European Medicines Agency’s priority medicines scheme. The company says its product is designed to make a significant impact on the growing problem of antimicrobial resistance.