FDA Approval Sought for Cilta-cel CAR T-cell Therapy

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FDA Approval Sought for Cilta-cel CAR T-cell Therapy
January 09, 2021January 9, 2021
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Janssen and Legend Biotech are seeking U.S. approval for their investigational CAR T-cell therapy ciltacabtagene autoleucel  — known as cilta-cel — to treat adults with relapsed or refractory (hard-to-treat) multiple myeloma. A rolling submission of the biologics license application (BLA) for cilta-cel has been started by Janssen with the U.S. Food and Drug Administration (FDA). Through this process, Janssen will submit individual sections of the application to the FDA as soon as each one is…

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