Novartis Receives CHMP Positive Opinion for Kymriah to Treat Follicular Lymphoma
- The recommendation was based on the P-II (ELARA) clinical study evaluating the safety & efficacy of Kymriah CAR-T cell therapy in patients with r/r FL after 2L+ systemic therapy
- After a median follow-up of 17mos. the efficacy results showed 86% had a response inc. CR (69%), 87% patients who showed CR still in response 9mos. after initial response demonstrated a prolonged durable response to treatment. The safety results within 8wks. of infusions showed 49% of CRS with no high-grade CRS
- The therapy is approved for the treatment of pediatric/young adults aged ≥25yrs. with r/r B cell ALL & for adults with r/r DLBCL. After the EC approval, r/r FL will be the third indication for Kymriah therapy in EU member states
Ref: Novartis | Image: Novartis
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