1. Pink Sheet
  2. >>Advanced Technologies
  3. >>Cell & Gene Therapies

CAR-T Development In Autoimmune Should Continue, FDA’s Marks Says; Malignancy Reports Not ‘Overly Concerning’

 
• By Sue Sutter

Although US FDA had received 22 adverse event reports by end of 2023, CAR-T products’ benefit-risk profiles remain ‘incredibly beneficial’ and the FDA has no concerns about approved oncology uses, Center for Biologics Evaluation and Research Director Peter Marks says.

Bright horizon
The horizon remains bright for CAR-T products despite malignancy reports. • Source: Shutterstock

Chimeric antigen receptor T-cell (CAR-T) therapies continue to have the blessing of the US Food and Drug Administration’s top cell and gene therapy regulator despite the agency’s high-profile safety alert about adverse event reports of T-cell malignancies.

The rate of T-cell malignancy reports with the products in the oncology setting is not “overly concerning,” and CAR-T product development should continue to move forward in autoimmune indications, Center...

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 Cell & Gene Therapies

More from Advanced Technologies