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

February 20, 2025 – On February 20, 2025, the U.S. Food and Drug Administration (FDA) announced it has approved acalabrutinib (Calquence, AstraZeneca) tablets and capsules in combination with venetoclax (Venclexta, AbbVie Inc. and Genentech Inc.) for adults with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). This combination is the first all-oral, fixed-duration regimen for the treatment of adult patients with CLL/SLL in the US.

Acalabrutinib (CALQUENCE, AstraZeneca) is a Bruton tyrosine kinase inhibitor. Bruton tyrosine kinase (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 them from several other treatment methods.

Venetoclax (Venclexta, AbbVie Inc. and Genentech Inc.) is an oral anticancer drug that can be taken by mouth. Oral agents are just as effective and can have similar side effects as anticancer drugs that are given intravenously.

“The FDA’s approval of the combination of acalabrutinib and venetoclax for adults with 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. “This expands the treatment options available to patients at the time of diagnosis, offering new hope and greater flexibility in care for a community that continues to seek more effective and tolerable therapies.”

For more information on the FDA approval of acalabrutinib (Calquence, AstraZeneca) in combination with venetoclax (Venclexta, AbbVie Inc. and Genentech Inc.), 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.