New FDA approval for Lilly's Jaypirca

The US Food and Drug Administration (FDA) on Friday approved another indication for Jaypirca (pirtobrutinib, 100mg and 50mg tablets) from US pharm major Eli Lilly (NYSE: LLY).

Previously granted accelerated approval by the FDA for relapsed or refractory mantle cell lymphoma (MCL), Jaypirca is now authorized for the treatment of 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. The drug has also received a positive recommendation from the European Medicines Agency.

Jaypirca was approved for the new indication under the FDA's Accelerated Approval pathway based on overall response rate (ORR) and duration of response (DOR) from the open-label, single-arm, multicohort, international, Phase I/II BRUIN trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.