Novartis CAR-T Therapy's Swift Approval Aided By REMS And New US FDA Review Model

Risk Evaluation and Mitigation Strategy for Kymriah requires the acute lymphoblastic leukemia treatment be administered by certified centers, while a postmarketing study will assess safety over 15 years. FDA's early approval reflects efforts by the biologics center and new cross-cutting Oncology Center for Excellence to implement a more collaborative review model.

FDA's swift approval of Novartis AG's chimeric antigen receptor T-cell therapy Kymriah (tisagenlecleucel) was aided by the company's Risk Evaluation and Mitigation Strategy (REMS), which requires hospitals dispensing the treatment to be certified.

FDA approved Kymriah, the first gene therapy to clear the agency, on Aug. 30 for the treatment of patients up...

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