Novartis’ Kymriah (tisagenlecleucel) CAR-T Cell Therapy Receives the US FDA’s Approval for the Treatment of Follicular Lymphoma
- The approval was based on the P-II (ELARA) trial evaluating Kymriah in 90 adult patients with r/r FL after ≥2 lines of systemic therapy for ~17mos. of median follow-up
- The results showed that 68% of patients achieved CR with ORR (86%) along with a remarkable safety profile, 85% were still in response @12mos. with sustained clinical benefit. The therapy was effective in high-risk patients including those with heavily pretreated or had refractory disease & other measures
- The safety profile was remarkable in 97 patients for safety @21mos. of median follow-up, 53% & 43% achieved any-grade CRS & neurologic events with no high-grade CRS, grade ≥3 neurologic events (6%), 18% were infused in an outpatient setting
Ref: Novartis | Image: Novartis
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