The FDA has granted accelerated approval to pirtobrutinib (Jaypirca, Eli Lilly and Company) on December 1, 2023, for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who’ve undergone at least two prior lines of therapy, including specific inhibitors (BTK inhibitor and a BCL-2 inhibitor).
The FDA’s approval of pirtobrutinib was based on BRUIN trial results. Key findings showed a 72% overall response rate and a median response duration of 12.2 months, all being partial responses. Common side effects (≥20%) included fatigue, bruising, cough, and musculoskeletal pain.
Serious infections affected 32% of patients, leading to fatal outcomes in 10%. The prescribed dose is 200 mg orally daily until disease progression or intolerable side effects, with safety precautions for various adverse events listed in the prescribing information.
Dr. William G. Wierda from MD Anderson Cancer Center noted that limited options exist for CLL or SLL patients progressing on certain therapies with poor outcomes. Jaypirca’s approval signifies a crucial advance, offering a much-needed treatment alternative for these patients.
He highlighted Jaypirca’s significance, introducing a new approach to targeting BTK and providing clinical benefit to a considerable number of patients in the BRUIN Phase 1/2 trial whose disease had advanced after prior treatments.
Dr. Brian Koffman, Chief Medical Officer and Executive Vice President at the CLL Society, acknowledged the substantial enhancements in CLL treatment through covalent BTK and BCL-2 inhibitors. He emphasized that the approval of Pirtobrutinib offers a vital option, introducing new possibilities for patients in their ongoing treatment path.
Source: Jaypirca® (pirtobrutinib) Now Approved by U.S. FDA for the Treatment of Adult Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Who Have Received at Least Two Lines of Therapy, Including a BTK Inhibitor and a BCL-2 Inhibitor
https://www.prnewswire.com/news-releases/jaypirca-pirtobrutinib-now-approved-by-us-fda-for-the-treatment-of-adult-patients-with-chronic-lymphocytic-leukemia-or-small-lymphocytic-lymphoma-who-have-received-at-least-two-lines-of-therapy-including-a-btk-inhibitor-and–302003695.html
