Pharmaceutical company Eli Lilly and Company (NYSE:LLY) announced on Wednesday that that it has received approval from US Food and Drug Administration (FDA) for its Jaypirca (pirtobrutinib, 100 mg & 50 mg tablets) for the treatment of adults with relapsed or refractory chronic lymphocytic leukaemia 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 converts the December 2023 accelerated approval for later-line CLL/SLL to a traditional approval.

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).

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