Legend Biotech Reports NMPA’s Acceptance of NDA for Ciltacabtagene Autoleucel (Cilta-Cel) in Multiple Myeloma
- This acceptance is based on data from the P-II study (CARTIFAN-1, NCT03758417), evaluated the efficacy and safety of cilta-cel in adult patients with r/r multiple myeloma who have received ≤3 or more prior lines of therapy, including a proteasome inhibitor and immunomodulatory drug
- Deep and durable responses showed by cilta-cel in the P-II study. Also, it has been approved for marketing in the US and Japan and has received conditional marketing authorization in the EU under the brand name Carvykti
- Cilta-Cel is a BCMA-directed, genetically modified CAR T-cell immunotx. that identifies and eliminates BCMA-expressing cells. In Dec 2017, the company collaborated with Janssen to develop and commercialize cilta-cel
Ref: Businesswire | Image: Legend
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