FDA Grants Accelerated Approval to Acalabrutinib for Mantle Cell Lymphoma


Calquence is a kinase inhibitor that blocks an enzyme crucial for cancer growth.

Today, the FDA granted accelerated approval to acalabrutinib (Calquence) for adults with mantle cell lymphoma who have received at least 1 previous treatment, according to a press release.

Mantle cell lymphoma is a rare and aggressive type of non-Hodgkin lymphoma, accounting for up to 10% of non-Hodgkin lymphoma cases in the United States. Mantle cell lymphoma affects the lymph system, which includes lymph tissue, lymph nodes, the spleen, thymus, tonsils, and bone marrow, according to the FDA. Upon diagnosis, the cancer has typically spread throughout the body.

Acalabrutinib is a kinase inhibitor that blocks an enzyme that is crucial for cancer growth and metastasis.

The FDA issued approval to acalabrutinib under the accelerated approval pathway due to the critically unmet needs of patients with mantle cell lymphoma; however, additional studies are needed to verify the clinical benefits of the drug, according to the release.

The new approval is based on positive findings from a clinical trial including 124 patients with mantle cell lymphoma. The investigators assessed how many patients experienced a complete or partial tumor shrinkage.

Approximately 81% of patients treated with acalabrutinib achieved a complete or partial response, according to the release.

Common side effects include headache, diarrhea, bruising, fatigue, muscle pain, anemia, thrombocytopenia, and neutropenia. The FDA warns that serious side effects can occur, including hemorrhaging, infections, and atrial fibrillation.

The FDA also cautions that second primary malignancies have occurred in certain patients treated with acalabrutinib, according to the release.

The application for acalabrutinib in mantle cell lymphoma was previously granted priority review, breakthrough therapy, and orphan drug designations, according to the FDA.

“Mantle cell lymphoma is a particularly aggressive cancer,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “For patients who have not responded to treatment or have relapsed, Calquence provides a new treatment option that has shown high rates of response for some patients in initial studies.”

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