U.S. FDA approves expanded indication for Lilly's Jaypirca (pirtobrutinib), the first and only non-covalent (reversible) BTK inhibitor, for adults with relapsed or refractory CLL/SLL previously treated with a covalent BTK inhibitor

Core Insights - The FDA has granted approval to Jaypirca (pirtobrutinib) for treating adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously been treated with a covalent BTK inhibitor, expanding its indication to a broader patient population [1][2] - This approval converts the December 2023 accelerated approval for later-line CLL/SLL to a traditional approval, allowing earlier use of Jaypirca in treatment plans [1] - Jaypirca is the first and only FDA-approved non-covalent BTK inhibitor, providing a new therapeutic option for patients who have progressed on covalent BTK inhibitors [1][2] Company Overview - Eli Lilly and Company is focused on advancing treatments for various health challenges, including cancers, through innovative drug development [2] - The company emphasizes the importance of making medicines accessible and affordable while ensuring clinical trials reflect diverse populations [2] Product Details - Jaypirca is a highly selective non-covalent BTK inhibitor, with a unique binding mechanism that allows it to target the BTK pathway effectively in patients previously treated with covalent BTK inhibitors [1] - The drug is available in 100 mg and 50 mg tablets, administered as a once-daily dose of 200 mg until disease progression or unacceptable toxicity [1] Clinical Trial Insights - The BRUIN CLL-321 trial, a Phase 3 randomized study, involved 238 patients and assessed the efficacy of Jaypirca compared to investigator's choice therapies [1] - The primary endpoint of the trial was progression-free survival (PFS), with secondary endpoints including overall response rate (ORR) and overall survival (OS) [1] Market Context - CLL is one of the most common types of leukemia in adults, with approximately 23,690 new cases expected in the U.S. this year [1] - The expanded indication for Jaypirca aligns with the NCCN Clinical Practice Guidelines, indicating a significant potential market for the drug among CLL/SLL patients [1]