Lilly's Jaypirca Gets Second Approval From FDA

(RTTNews) - Eli Lilly and Co (LLY) announced that FDA approved Jaypirca (pirtobrutinib, 100 mg & 50 mg tablets) for adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a Bruton's tyrosine kinase (BTK) inhibitor and a BCL-2 inhibitor.

Jaypirca, the first and only non-covalent (reversible) BTK inhibitor, has been shown to extend the benefit of BTK inhibition.

The company specified that Jaypirca was approved under the FDA's Accelerated Approval pathway based on overall response rate (ORR) and duration of response (DOR) from Phase 1/2 BRUIN trial.

In the BRUIN Phase 1/2 trial, adult patients with CLL/SLL who have received at least two lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor, achieved an overall response rate of 72%, the company noted.

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

This is the second FDA-approved indication for Jaypirca following the January 2023 Accelerated Approval for adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor.

"The treatment landscape for CLL Has been dramatically improved by the introduction of covalent BTK inhibitors and BCL-2 inhibitors", said Dr. Brian Koffman, chief medical officer and executive vice president at the CLL Society. "Pirtobrutinib's approval gives patients a much-needed option and brings forward new possibilities as they continue their treatment journey."