The US Food and Drug Administration (FDA) has approved Eli Lilly’s Jaypirca (pirtobrutinib, 50 mg and 100 mg tablets) for the treatment of adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent Bruton tyrosine kinase (BTK) inhibitor.

This approval expands the Jaypirca label to include patients earlier in their treatment course and also converts the December 2023 accelerated approval for later-line CLL/SLL to a traditional approval.  

"Pirtobrutinib is the only medicine in CLL or SLL that has been prospectively studied in a randomised trial of patients previously treated with a covalent BTK inhibitor, and I am excited to see this expanded FDA approval recognise the benefit it can deliver to this broader group of patients," said Jeff Sharman, Disease Chair, Hematology Executive Committees, SCRI at Willamette Valley Cancer Institute and Research Centre, and one of the principal investigators of the BRUIN CLL-321 trial.

"When covalent BTK inhibitors are no longer an option due to disease progression or intolerance, pirtobrutinib enables physicians to extend the benefits of targeting the BTK pathway, offering continuity in the CLL or SLL treatment experience,” he added.

Jaypirca, the first and only FDA-approved non-covalent (reversible) BTK inhibitor, is a highly selective kinase inhibitor that utilises a novel non-covalent binding mechanism to extend the benefit of targeting the BTK pathway in patients with relapsed or refractory CLL/SLL previously treated with a covalent BTK inhibitor (ibrutinib, acalabrutinib, or zanubrutinib).

Jacob Van Naarden, executive vice president and president of Lilly Oncology, said, "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. With robust efficacy and safety evidence from the only study of its kind in the post-covalent 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.”

Lilly is studying Jaypirca in CLL/SLL in multiple Phase 3 studies.