FDA Approves Expanded Use Of Lilly's Jaypirca For CLL/SLL

(RTTNews) - Eli Lilly and Company (LLY) announced that the U.S. Food and Drug Administration approved an expanded indication for Jaypirca (pirtobrutinib) to treat adults with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have no known 17p deletion.

The approval allows Jaypirca to be used as a first-line treatment for eligible patients. Jaypirca is the first and only FDA-approved non-covalent Bruton tyrosine kinase (BTK) inhibitor and is designed to selectively target the BTK pathway through a novel non-covalent binding mechanism.

The drug's label includes warnings and precautions related to infections, hemorrhage, cytopenias, cardiac arrhythmias, second primary malignancies, hepatotoxicity including drug-induced liver injury, and embryo-fetal toxicity.

Lilly is continuing to evaluate Jaypirca in multiple Phase 3 studies in CLL/SLL as it seeks to expand treatment options for patients with blood cancers.

LLY closed Friday's regular trading at $1,142.85 down $7.00 or 0.61%.