The U.S. Food and Drug Administration (FDA) Approves Acalabrutinib (CALQUENCE) for Mantle Cell Lymphoma

January 16, 2025 – On January 16, 2025, the U.S. Food and Drug Administration (FDA) announced it has approved acalabrutinib (CALQUENCE, AstraZeneca) with bendamustine and rituximab for adults with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT).

The FDA also granted traditional approval to acalabrutinib as a single agent for adults with previously treated MCL. Acalabrutinib received accelerated approval for this indication in 2017.

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 it from several other treatment methods.  

Meghan Gutierrez, Chief Executive Officer of the Lymphoma Research Foundation, said: “New treatment options have long been needed in the first-line treatment of mantle cell lymphoma. We recognize the patients, clinicians and scientists who have made this advancement possible.”

For more information on the FDA approval of acalabrutinib (CALQUENCE, AstraZeneca), visit the FDA’s website.