FDA Grants Traditional Approval to Pirtobrutinib for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

On December 3, the FDA 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.

For more information, read the FDA announcement and the Lilly press release.

Posted on 12/5/2025