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: GlobeNewswire | Image: Magenta Therapeutics
Related News: https://pharmashots.com/14276/eli-lilly-and-boehringer-ingelheim-report-the-us-fda%E2%80%99s-acceptance-of-snda-for-jardiance-empagliflozin
