1. Pink Sheet
  2. >>Geography
  3. >>North America
  4. >>United States

Ariad’s Leukemia Drug Iclusig Sails Through FDA In Less Than 3 Months

 
• By Sue Sutter

Ponatinib received accelerated approval for use in chronic myeloid leukemia and acute lymphoblastic leukemia patients who are resistant or intolerant to prior therapy with tyrosine kinase inhibitors.

The three-month early approval of Ariad Pharmaceuticals Inc.’s leukemia drug Iclusig (ponatinib) is yet another demonstration of the speed at which FDA has cleared novel cancer medicines in recent years, even before the advent of new provisions in the FDA Safety and Innovation Act aimed at expediting the development and approval of “breakthrough” and other innovative therapies.

The agency granted accelerated approval to ponatinib on Dec. 14, more than three months ahead of the drug’s March 27,...

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 United States

ANDA User Fees: Complex Generics, Transparency, Communications Are Early Negotiation Targets

 
• By Sue Sutter

Teva seeks a dedicated development program and first-cycle approval metrics for complex generics. Role of artificial intelligence in the generic drug review process is a talking point for both agency and industry at reauthorization kickoff meeting.

US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 
• By Bridget Silverman

The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.

US FDA Asking Questions About Commissioner’s Voucher Program With Details Scarce

 
• By Derrick Gingery

FDA staff are trying to plan for program implementation in the absence of critical eligibility and other details, although guidance may be coming soon.

Senate Appropriators Give US FDA More Non-User Fee Funds Than House

 
• By Sarah Karlin-Smith

US FDA would receive more funding for fiscal year 2026 in the Senate appropriations bill than its House counterpart, including $10m for unannounced foreign inspections.

More from North America

Animal Testing: US And EU Regulatory Support Grows For Alternatives, But Validation A Hurdle

 
• By Eliza Slawther

In this first of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet how the use of alternatives to animal testing in drug development is gaining traction and discusses the challenges that exist.

Senate Panel Approves US CDC Director Candidate Monarez With Measles Outbreak Growing

 
• By Cathy Kelly

The Senate Health, Education, Labor and Pensions Committee voted to advance Monarez's nomination to lead the CDC as the agency announced the largest US measles outbreak in 22 years.

US FDA Advisory Committee Supports Vaccine Safety, Scrutinizes AE Reporting Quality

 
• By Sue Sutter

The Pediatric Advisory Committee supported routine safety monitoring for three vaccines and 21 drugs, but the panel’s consumer representative said adverse event reporting needs improvement and FDA literature reviews should include lawsuits as well as social media.