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ARTICLE | Regulation

Marks: CAR T cancer risk is acceptable, at least for oncology applications

FDA’s Peter Marks discloses 22 cases of secondary T cell malignancies in U.S. patients treated with CAR Ts

By Lauren Martz, Executive Director, Biopharma Intelligence
January 9, 2024 12:05 AM UTC

The risk of secondary malignancies from CAR T cells that shook cell therapy developers late last year shouldn’t derail CAR T development for cancer, according to CBER Director Peter Marks, but the fate of other CAR T cell applications is up for debate.

During the Alliance for Regenerative Medicine (ARM) Cell & Gene Therapy State of the Industry briefing at the J.P. Morgan Healthcare Conference on Monday, Marks provided an update on the incidence of the serious adverse events...

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