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Relmacabtagene autoleucel receives China NMPA supplementary biological application approval for R/R MCL
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On August 27, 2024, it was announced that the China National Medical Products Administration (NMPA) approved a supplementary biological application for relmacabtagene autoleucel (relma-cel), a CD20-directed chimeric antigen receptor T-cell therapy, for the treatment of adult patients with relapsed/refractory mantle cell lymphoma after ≥2 prior lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor. This approval was based on positive results from the pivotal trial conducted in China.
Key data from the pivotal trial
Among the evaluable patients with mantle cell lymphoma (n = 59):
- Best objective response rate was 81.36%
- Best complete response rate was 67.80%
- Grade ≥3 cytokine release syndrome and Grade ≥3 neurotoxicity each occurred in 6.8%
- PR Newswire. JW Therapeutics announces NMPA approval of the supplemental biological license application for Carteyva® in adult patients with relapsed or refractory mantle cell lymphoma. https://www.prnewswire.com/news-releases/jw-therapeutics-announces-nmpa-approval-of-the-supplemental-biological-license-application-for-carteyva-in-adult-patients-with-relapsed-or-refractory-mantle-cell-lymphoma-302231445.html. Published Aug 27, 2024. Accessed Aug 30, 2024.
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