CAR-T Therapies: Stakeholders Urge Rethinking Of Postmarketing Requirements And REMS

Long-term follow-up requirements have taken a conservative approach, but could be ripe for re-examination and global harmonization, Kite Pharma executive director says, while former FDA gene/cell therapy office head Wilson Bryan wants the classwide REMS eliminated.

Reflect, rethink, revise
CAR-T therapy postmarketing safety requirements could be ripe for re-examination. • Source: Shutterstock

The maturation of the CAR-T therapy field may be cause for re-evaluation of some of the early postmarketing regulatory requirements for the cell-based gene therapies.

Long-term follow-up obligations could be reduced, and the existing Risk Evaluation and Mitigation Strategy for the class could be eliminated, given the real-world experience with the products to date, experts said

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