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

October 2, 2026 – On October 2, 2026, the U.S. Food and Drug Administration (FDA) announced it approved pirtobrutinib (Jaypirca, Eli Lilly and Company) for adult patients with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with no known 17p deletion.

Pirtobrutinib was previously approved for adults with relapsed or refractory CLL/SLL who had previously been treated with a covalent BTK inhibitor.

Pirtobrutinib (Jaypirca, Eli Lilly and Company) is a Bruton tyrosine kinase inhibitor (BTK). 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.

“The FDA’s approval of pirtobrutinib for frontline chronic lymphocytic leukemia/small lymphocytic lymphoma is an important advancement for people facing this disease,” said Meghan Gutierrez, Chief Executive Officer of the Lymphoma Research Foundation. “Bringing this therapy into the first-line setting expands the treatment options available to patients at diagnosis and offers new hope for a community that continues to seek effective, well-tolerated therapies..”

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/small lymphocytic lymphoma (CLL/SLL), visit the Foundation’s chronic lymphocytic leukemia or small lymphocytic lymphoma learning center.