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Approval Delayed, But Janssen/Legend’s Cilta-Cel May Hit Market Just In Time

BMS/Bluebird’s Abecma Approved But Demand Exceeds Supply

 
• By Mandy Jackson

The US FDA has extended the user fee date by three months for the partners’ BCMA-targeting CAR-T therapy but its first-to-market rival is facing manufacturing challenges that limit access to treatment.

Close up of hourglass clock on a wooden floor
Time will tell if a three-month approval delay is meaningful for cilta-cel • Source: Alamy

Janssen Pharmaceutical Cos. and Legend Biotech Corp. will have to wait an extra three months for a US Food and Drug Administration approval decision on their chimeric antigen receptor T-cell therapy ciltacabtagene autoleucel (cilta-cel) but given the manufacturing challenges facing first-to-market Abecma (idecabtagene vicleucel) there may be pent-up demand for another B-cell maturation antigen (BCMA)-targeting CAR-T product by the time cilta-cel reaches the market for multiple myeloma.

Johnson & Johnson subsidiary Janssen and Legend announced on 1 November that the FDA has moved the action date for the cilta-cel biologic license application for treatment of relapsed or refractory multiple myeloma from 29 November to 28 February

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