Eli Lilly’s Jaypirca (pirtobrutinib) Receives the US FDA’s Accelerated Approval for the Treatment of Mantle Cell Lymphoma
- The US FDA has approved Jaypirca (100/50mg) for adult patients with r/r MCL after two lines of systemic therapy. The approval was based on the P-I/II trial (BRUIN) includes a P-I dose-escalation phase, a P-Ib combination arm, and a P-II dose-expansion phase evaluating Jaypirca in 120 patients
- The results showed that patients treated with Jaypirca (200mg) achieved an ORR (50%), CR (13%), PR (38%), and median time to response (1.8mos.) and m-DoR was 8.3mos., 6mos. DoR rate (65.3%) while 83% discontinued the last BTK inhibitor due to refractory or progressive disease. In the pooled safety analysis, adverse reactions were reported in ≥20%
- Dose reductions & treatment interruptions due to AEs in 4.7% & 32%, respectively, and permanent discontinuation of the study drug (9%)
Ref: PRNewswire | Image: Eli Lilly
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