The FDA has approved pirtobrutinib (Jaypirca) for adults with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) lacking del(17p), based on results from the randomized, open-label, active-controlled BRUIN CLL-313 trial. The agency’s decision marks a first-line expansion for a noncovalent BTK inhibitor that previously supported later-line use.