The U.S. Food and Drug Administration (FDA) Approves Pirtobrutinib for Relapsed/Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

December 3, 2025 – On December 3, 2025, the U.S. Food and Drug Administration (FDA) announced it has approved pirtobrutinib (Jaypirca, Eli Lilly and Company) for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent Bruton tyrosine kinase (BTK) inhibitor.

Pirtobrutinib (Jaypirca, Eli Lilly and Company) is a BTK inhibitor. BTK is a protein critical for the growth and survival of B-cells. BTK inhibitors can kill malignant B-cells but leave healthy T-cells largely unaffected, which distinguishes it from several other treatment methods.

“This approval represents an important advancement for people living with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma,” said Meghan Gutierrez, Chief Executive Officer of the Lymphoma Research Foundation. “We applaud the patients, families, and care teams whose dedication and resilience continue to pave the way for brighter futures for all those touched by these diseases.”

For more information on the FDA approval of pirtobrutinib (Jaypirca, Eli Lilly and Company), visit the FDA’s website. To learn more about treatment options for chronic lymphocytic leukemia or small lymphocytic lymphoma, visit the Foundation’s chronic lymphocytic leukemia or small lymphocytic lymphoma learning center.