FDA grants traditional approval to pirtobrutinib for CLL, SLL

The Food and Drug Administration has granted traditional approval to pirtobrutinib for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who have previously been treated with a covalent BTK inhibitor. In 2023, FDA granted accelerated approval to pirtobrutinib for adults with CLL/SLL who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor. Efficacy was evaluated in BRUIN-CLL-321, a randomized, open-label, active-controlled trial. The trial randomized 238 patients who were previously treated for CLL/SLL, including a covalent BTK inhibitor. Median PFS was 11.2 months in the pirtobrutinib arm and 8.7 months in the investigator’s choice of IR/BR arm. Of the 119 patients in the investigator’s choice arm, 50 crossed over to receive JAYPIRCA therapy. At an updated analysis with a median follow-up time of 19.8 months, the HR for overall survival was 1.09. The manufacturer of Jaypirca is Eli Lilly (LLY).