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Eli Lilly’s Jaypirca (pirtobrutinib) Receives the US FDA’s Accelerated Approval for the Treatment of Mantle Cell Lymphoma

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Eli Lilly’s Jaypirca (pirtobrutinib) Receives the US FDA’s Accelerated Approval for the Treatment of Mantle Cell Lymphoma

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  • 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

Related News: Eli Lilly and Boehringer Ingelheim Report the US FDA’s Acceptance of sNDA for Jardiance (empagliflozin) to Treat Chronic Kidney Disease

Click here to­ read the full press release 

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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