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

Iclusig Experience Reflects Regulatory Risk Inherent With Accelerated Approval

 
• By Sue Sutter

FDA reviewers and outside experts discussed at length concerns about cardiovascular and other adverse events in the single-arm PACE trial but believed ponatinib’s impressive efficacy in a difficult-to-treat leukemia population warranted bringing the drug to market. Sales of the tyrosine kinase inhibitor were halted less than 11 months later as safety and dosing concerns continued to pile up.

Rather than representing a failure of FDA’s accelerated approval process, Ariad Pharmaceuticals Inc.’s halt in sales of its leukemia drug Iclusig (ponatinib) due to increasing rates of cardiovascular-related adverse events should be a reassuring sign to industry that the agency is willing to take calculated risks when faced with an efficacious drug.

That FDA requested ponatinib come off the market pending a benefit/risk re-evaluation less than 11 months after accelerated approval might call into question whether the agency’s super-speedy review, officially clocked at less than three months, led to potential safety

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

Medicare Negotiation Does Not Violate Due Process, Appeals Court Rules, Other Suits At Risk

 
• By Cathy Kelly

Decision in AstraZeneca’s lawsuit against the Health and Human Services Department is a precedent-setting victory for the government and a blow to manufacturer efforts to block the price negotiation program.

Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
• By Bridget Silverman

Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.

Pink Sheet Podcast: A New Director For US FDA’s Biologics Center, Guidance Production Slowdowns

 
• By Derrick Gingery, Sue Sutter, and Nielsen Hobbs

Pink Sheet editors discuss the appointment of Vinay Prasad as the new director of the Center for Biologics Evaluation and Research and revelations that FDA layoffs now are hindering development of guidance documents.

US FDA Restoring Some Library Resources

 
• By Sue Sutter and Derrick Gingery

Agency staff once again have access to the Lexis-Nexis legal and news database, but are still waiting for access to journals, and laid off librarians have not been reinstated.

More from North America

Recent and Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

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

Most Favored Nation Pricing Policy Floated In Medicaid, Coming Back To Medicare?

 
• By Cathy Kelly

President Trump's ongoing interest in the policy, which would ensure the US government pays no more for prescription drugs than the lowest price available in comparable countries, continues to gain attention.

US FDA Advisory Committee Misperceptions Abound … At HHS

 
• By Michael McCaughan

HHS Secretary Robert F. Kennedy Jr. regularly decries the “conflicts of interest” he believes abound in advisory committees, but his concerns, as well as a recent “policy directive” eliminating industry representatives, seem driven by a misunderstanding of the panels’ jobs.