The U.S. Food and Drug Administration on Friday approved an additional indication of Jaypirca (pirtobrutinib), enabling Eli Lilly and Co. (NYSE:LLY) to market the drug as a first-line treatment for adult patients with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma without a known 17p deletion.
Clinical Trial Demonstrates Superior Progression-Free Survival
Jaypirca, supplied in 100 mg and 50 mg tablets, stands as the first and only FDA-approved non-covalent Bruton tyrosine kinase inhibitor.
This highly selective therapy utilizes a unique non-covalent binding mechanism to target the BTK pathway.
Regulators backed the decision using primary analysis data from the randomized Phase 3 BRUIN CLL-313 clinical study.
Data from the BRUIN CLL-313 study revealed that Jaypirca significantly enhanced progression-free survival over bendamustine plus rituximab at a median follow-up of 28 months, with a hazard ratio of 0.20.
Patients treated with Jaypirca achieved an overall response rate of 94%, including a 13% complete response rate, while median progression-free survival remained unreached compared to 33.5 months in the control arm.
Safety Profile And Medical Guidelines Integration
The National Comprehensive Cancer Network lists Jaypirca as the only recommended non-covalent BTK inhibitor in its medical guidelines.
The network assigns Jaypirca Category 2A status for treatment-naïve patients without del(17p) and Category 1 preferred status for relapsed or refractory patients previously given covalent BTK inhibitors.
Lilly continues to evaluate Jaypirca in multiple Phase 3 clinical studies.
In April, Eli Lilly shared results from the Phase 3 BRUIN CLL-322 trial of Jaypirca (pirtobrutinib), which showed significant improvement in progression-free survival when combined with venetoclax and rituximab.
The trial included patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL).
LLY Price Action: Eli Lilly shares were trading higher by 1.68% at $1,162 at the time of publication on Monday, according to Benzinga Pro data.
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