FDA Approves Expanded Indication for Jaypirca

TUESDAY, Dec. 9, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has approved an expanded indication for Jaypirca (pirtobrutinib), the first and only noncovalent Bruton tyrosine kinase (BTK) inhibitor for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) previously treated with a covalent BTK inhibitor.This action expands the Jaypirca labeling to include patients earlier in their treatment course and converts the December 2023 accelerated approval for later-line CLL/SLL to a traditional approval. Jayprica is available in 50- and 100-mg tablets and is a selective kinase inhibitor that utilizes a noncovalent binding mechanism to extend the benefit of targeting the BTK pathway.The approval is based on results from the phase 3 BRUIN CLL-321 trial, an open-label study that randomly assigned 238 patients to receive Jaypirca (200 mg orally, once daily) or investigator's choice of either idelalisib plus rituximab or bendamustine plus rituximab. The primary end point of the BRUIN CLL-321 trial is progression-free survival."This label expansion allows physicians to use Jaypirca directly after a covalent BTK inhibitor, the setting where we have always believed it has its most unique potential impact for patients," Jacob Van Naarden, executive vice president and president of Lilly Oncology, said in a statement. "With robust efficacy and safety evidence from the only study of its kind in the postcovalent BTK inhibitor treatment setting, we're proud to now offer this therapy to more patients with CLL or SLL at an earlier stage of their treatment plan."This approval was granted to Eli Lilly.More Information.Sign up for our weekly HealthDay newsletter

FDA Approves Expanded Indication for Jaypirca

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