FDA decision expands frontline CLL treatment

The FDA approved Eli Lilly’s pirtobrutinib (Jaypirca) for adults with previously untreated CLL or SLL who do not have del(17p), moving the noncovalent BTK inhibitor into first-line care. The decision was based on the randomized, open-label, active-controlled phase 3 BRUIN CLL-313 trial (n=282).