FDA Approves Pirtobrutinib for Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

The U.S. Food and Drug Administration (FDA) has expanded the approval of pirtobrutinib (Jaypirca) as a first-line monotherapy for adult patients with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) without a known 17p deletion. This decision is based on data from the Phase 3 BRUIN CLL-313 trial, which showed a statistically significant improvement in progression-free survival with pirtobrutinib compared to standard chemoimmunotherapy.