FDA Grants Accelerated Approval to Jaypirca for CLL and SLL

The FDA granted accelerated approval to pirtobrutinib (Jaypirca, Eli Lilly) for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK (Bruton’s tyrosine kinase) and BCL-2 (B-cell leukemia/lymphoma-2) inhibitor.

Efficacy was evaluated in BRUIN (ClinicalTrials.gov Identifier: NCT03740529], an open-label, international, single-arm, multicohort trial that included 108 patients with CLL or SLL