Lilly USA, LLC is pleased to announce that the US Food and Drug Administration (FDA) has approved Jaypirca™ (pirtobrutinib), 50 mg and 100 mg tablets, on January 27, 2023, for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL) after at least 2 lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.
This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. For additional information, please see the press release here.
Please click for Prescribing Information and Patient Information for Jaypirca.