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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 Cell & Gene Therapies

Prasad Says Involvement In US FDA Product Approvals Will Mirror Prior CBER Directors

 
• By Sarah Karlin-Smith

The remarks from the new CBER director suggest Prasad will not be involved in most product-specific decisions.

US FDA Cell-Gene Therapy Head Says Agency Has Revived Stalled Programs

 
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CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products.

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By Vibha Sharma

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.

House Budget Bill Includes Delayed Orphan Fix, Also Risks Downstream Cell and Gene Coverage

 
• By Sarah Karlin-Smith

The first two classes of negotiated drugs under the Inflation Reduction Act would not benefit from a rare disease adjustment House Republicans included in their reconciliation package.

More from Advanced Technologies

US FDA Cell-Gene Therapy Head Says Agency Has Revived Stalled Programs

 
• By Sarah Karlin-Smith

CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products.

EMA Says Digital Transformation A ‘Fundamental Shift’ In Meeting Regulatory Challenges

 
• By Eliza Slawther

Sponsors can expect faster evaluation processes for key medicines and greater support in mitigating medicines supply shortages this year as part of the European Medicines Agency’s digital transformation overhaul.

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By Vibha Sharma

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.