Ariad Unfazed By FDA Breakthrough Denial

FDA denied a “breakthrough” designation request for ALK/EGFR inhibitor AP26113, but the door is open for another try, and the undaunted company is launching a pivotal trial in NSCLC this quarter. Ariad also reported a continued successful launch of its leukemia drug Iclusig.

Ariad Pharmaceuticals Inc. was denied a breakthrough designation from FDA for its ALK/EGFR inhibitor AP26113 in non-small cell lung cancer, the company admitted during its second quarter earnings call, though the firm may try again.

The request was denied “because of the relatively short follow-up of many of the ALK-positive patients treated with ‘113 to...

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

More from Clinical Trials

More from R&D