Eli Lilly and Company announced it has received expanded approval from the U.S. Food and Drug Administration (FDA) for its cancer treatment, Jaypirca. The drug is now approved for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have been previously treated with another specific type of inhibitor. This decision is significant as it converts a prior accelerated approval from December 2023 into a traditional, full approval and broadens the drug's label to include patients at an earlier stage of their treatment journey. Jaypirca is the first and only non-covalent BTK inhibitor to receive this expanded indication, based on positive results from the randomized Phase 3 BRUIN CLL-321 clinical trial.
Eli Lilly Gains Expanded FDA Approval for Cancer Drug Jaypirca
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