On 12/03/2025 FDA granted traditional (full) approval to pirtobrutinib (Jaypirca®) for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received a prior covalent BTK inhibitor.
This approval converts the prior accelerated approval and removes the requirement for prior BCL-2 inhibitor exposure, allowing use immediately after covalent BTK inhibitor failure.
Approval is supported by the phase 3 BRUIN-CLL-321 trial, which demonstrated a significant improvement in progression-free survival versus investigator’s choice chemoimmunotherapy.
Pirtobrutinib is a highly selective, non-covalent (reversible) BTK inhibitor designed to overcome resistance to covalent BTK inhibitors. The recommended dose is 200 mg orally once daily until disease progression or unacceptable toxicity.