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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...

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More from Advanced Technologies

Scientists Work With AI To Uncover ‘Unexpected’ Drug Combos For Breast Cancer

 
• By Natasha Barrow

A UK research team has used artificial intelligence to find new treatments for cancer using existing US Food and Drug Administration-approved medicines that are not normally not used for the disease.

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