JW’s Relmacabtagene Autoleucel Receives the NMPA’s Approval for the Treatment of R/R Large B-Cell Lymphoma in China

Shots:

• The approval is based on a RELIANCE study that evaluates efficacy & safety of relma-cel in 59 patients with r/r LBCL who had failed at least 2L of therapy, including CD20 agent & anthracycline & patients continue to be monitored for 2+ yrs.
• The results showed the high rates of durable disease response & low rate of CAR-T associated toxicities. As of Jun 17, 2020, study showed ORR (75.9%), CRR (51.7%), patients achieved CRS & NT of >grade 3 (5.1% & 3.4%), rates for severity grade CRS & NT (47.5% & 20.3%) respectively
• Relma-cel is 1st CAR-T product approved as category 1 biologics in China. The therapy has received PR & BTD & is included in National Significant New Drug Development Program

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