1. Pink Sheet
  2. >>Pathways & Standards
  3. >>Approval Standards

Bristol/Agios AML’s Idhifa Fails In Phase III, But Approval Seems Secure

 
• By Mandy Jackson

Idhifa is already approved in the US for relapsed or refractory AML patients with IDH2 mutations based on Phase I/II complete responses, but did not meet the overall survival endpoint in the Phase III IDHENTIFY.

microscope
Idhifa missed the overall survival endpoint in Phase III

Bristol-Myers Squibb Company’s IDH2 inhibitor Idhifa (enasidenib) did not meet the primary endpoint of overall survival (OS) in the Phase III IDHENTIFY clinical trial in patients with relapsed or refractory acute myeloid leukemia, but the result may not imperil its marketing status since the product has already received received full, not accelerated approval, from the FDA.

Idhifa was approved in the US in 2017 for adults with relapsed or refractory AML with IDH2 mutations. Agios...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Approval Standards

Podium Policy Returns To US FDA, Or Is It Podcast Policy?

 
• By Michael McCaughan

US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.

EMA Explores Supporting Drug Development For High Unmet Need Disorder Scleroderma

 
• By Neena Brizmohun

While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.

Post-Approval, Real-Time Monitoring Will Help Approval Standards, US FDA’s Makary Says

 
• By Sue Sutter

The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.

Generic Drug Office’s Policy Staff Returning To US FDA

 
• By Derrick Gingery

The group had been laid off as part of the 1 April reduction-in-force, which led to missed guidance publication deadlines.

More from Pathways & Standards

EMA Explores Supporting Drug Development For High Unmet Need Disorder Scleroderma

 
• By Neena Brizmohun

While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.

First Among Equals: US FDA CBER Director Prasad Gains Agency-Wide Authority

 
• By Bridget Silverman

As Chief Medical and Scientific Officer, Vinay Prasad will advise the FDA Commissioner on cross-cutting issues, provide strategic leadership and be a public face of the agency.

National Priority Voucher Gives US FDA Commissioner Tool For Radical Regulatory Surgery

 
• By Bridget Silverman

US FDA Commissioner Martin Makary will establish "national priorities" used to select sponsors for the pilot of “tumor board-style” drug reviews that would start before Phase III is completed.