JW's Relmacabtagene Autoleucel Receives the NMPA's Approval for the Treatment of R/R Large B-Cell Lymphoma in China
- 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
| Ref: Cision PR Newswire | Image: FinSMEs
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