Eli Lilly and Company announced that the U.S. FDA approved Jaypirca for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least two prior lines of therapy, including a Bruton’s tyrosine kinase inhibitor and a BCL-2 inhibitor. Jaypirca was approved under the FDA’s Accelerated Approval pathway based on overall response rate and duration of response from the open-label, single-arm, multicohort, international, Phase 1/2 BRUIN trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
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