Agios Pharmaceuticals (AGIO) has already announced plans to seek U.S. approval for its second leukemia drug by the end of the year. On Wednesday, the biotech firm provided a peek at some of the clinical trial data that will support the new filing.

The Agios drug is called ivosidenib, and it works by blocking a mutated enzyme, IDH1, that is found in 6 to 10 percent of patients with acute myeloid leukemia (AML), a type of blood cancer that forms in the bone marrow and causes unchecked growth of abnormal white blood cells.

Unlock this article by subscribing to STAT Plus and enjoy your first 30 days free!

GET STARTED

What is it?

STAT Plus is STAT's premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond.

What's included?

  • Daily reporting and analysis
  • The most comprehensive industry coverage from a powerhouse team of reporters
  • Subscriber-only newsletters
  • Daily newsletters to brief you on the most important industry news of the day
  • Online intelligence briefings
  • Frequent opportunities to engage with veteran beat reporters and industry experts
  • Exclusive industry events
  • Premium access to subscriber-only networking events around the country
  • The best reporters in the industry
  • The most trusted and well-connected newsroom in the health care industry
  • And much more
  • Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr.

Leave a Comment

Please enter your name.
Please enter a comment.

  • So, if Agios is seeking end of the year filing ; is that breakthrough status ? If so, under the new FDARA Act, Race For Children , they are supposed to post expanded access policy and contact info. To allow a chance at life for those many not in their small, slow trials. Not that they shouldn’t already be doing the right moral thing , but that is lacking in PHRMA World…

A roundup of STAT’s top stories of the day in science and medicine

Privacy Policy