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Lynparza Approval Shows Benefit/Risk Contrast In Maintenance, Relapse Settings

 
• By Sue Sutter

AstraZeneca’s olaparib gains accelerated approval for fourth-line treatment of ovarian cancer – a different indication than the maintenance claim publicly vetted and rejected by FDA’s Oncologic Drugs Advisory Committee due to the drug’s toxicities and concerns about the reliability of progression-free survival data.

FDA’s approval of AstraZeneca PLC’s ovarian cancer drug Lynparza (olaparib) reflects the different prisms through which the agency views benefit/risk in the relapse and maintenance settings.

It also shows an agency – and particularly an oncology review division – willing to go the extra mile to...

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More from United States

Recent And Upcoming FDA Advisory Committee Meetings

 
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

US FDA Could Miss User Fee Spending Triggers With House FY 2026 Funding

 
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• By Tim Casey

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• By Cathy Kelly

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More from North America

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• By Vibha Sharma

The whole contract research organization industry is being impacted by the current volatility in the pharmaceutical industry.

Anti-Vaccine Activists Among New US CDC Vaccine Advisors

 
• By Sarah Karlin-Smith

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US FDA May Consolidate Support Services After Extensive Cuts

 
• By Derrick Gingery and Sue Sutter

Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.