FDA Asks for More Data on Ide-cel as Potential Multiple Myeloma Therapy

The U.S. Food and Drug Administration (FDA) asked for more information from Bristol Myers Squibb and Bluebird Bio as it considers a request to approve their lead CAR T-cell therapy — idecabtagene vicleucel (ide-cel; bb2121) — for heavily pre-treated patients with multiple myeloma. The agency’s refusal letter requested further details on the potential therapy’s chemistry, manufacturing and control — or CMC module, necessary to ensure treatment safety, quality and potency — to continue the review process, the companies reported. No…

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