The U.S. Food and Drug Administration on Friday approved an additional indication for Jaypirca (pirtobrutinib), giving Eli Lilly and Co. (LLY) the green light 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 uses 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. That data revealed 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 market data.