Eli Lilly and Co. (LLY) announced that the U.S. Food and Drug Administration (FDA) has approved Jaypirca (pirtobrutinib, 100 mg and 50 mg tablets) for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously received therapy with a covalent Bruton tyrosine kinase (BTK) inhibitor.
This FDA decision expands the Jaypirca label to include patients earlier in their treatment journey, broadening access to the therapy. In addition, the approval converts the December 2023 accelerated approval for later-line CLL/SLL into a traditional approval, reflecting the strength of the clinical data supporting Jaypirca's efficacy and safety profile. Jaypirca, the first and only FDA-approved non-covalent (reversible) BTK inhibitor, is a highly selective kinase inhibitor that utilizes 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).
LLY closed Wednesday's regular trading session at $1,033.56, down $12.56 or 1.20%. In overnight trading, the stock declined $7.35 or 0.71%, as of 8:32 PM EST.
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