FDA Approves New Treatment for Adults With Mantle Cell Lymphoma

The US Food and Drug Administration granted accelerated approval of acalabrutinib (Calquence) for treating adult patients with mantle cell lymphoma who have received at least 1 prior therapy.

Mantle cell lymphoma, a cancer of the lymph system, is a rare and fast-spreading type of non-Hodgkin lymphoma. It represents 3% to 10% of all non-Hodgkin lymphoma cases in the US, according to the National Cancer Institute. By the time mantle cell lymphoma is diagnosed, it often has already spread to the lymph nodes, bone marrow, and other organs.

“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 of Drug Evaluation and Research, in a statement. “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.”

Calquence is a kinase inhibitor that works by blocking an enzyme the cancer needs to multiply and spread.

Yesterday's approval of Calquence to AstraZeneca was based upon data from a single-arm trial that analyzed 124 adult patients with mantle cell lymphoma who had received at least 1 prior treatment. The trial assessed the overall response rate of patients experiencing partial or complete shrinkage of their tumors after treatment, finding that 41% of patients had a partial response and 40% had a complete response, for an overall response rate of 81%.

The drug’s side effects include bleeding, infections, and irregular heartbeat. Additional cancers have occurred in some patients. Women who are breastfeeding are advised not to take Calquence because it could harm the baby.

Calquence was approved by the FDA through the Accelerated Approval pathway, which allows the approval of drugs for serious conditions where there is currently an unmet need if a drug is shown to have certain effects that are likely to produce clinical benefits to patients. The FDA granted the application Priority Review and Breakthrough Therapy designations. The drug also received Orphan Drug designation, which provides incentives to manufacturers to assist and encourage development for drugs to treat rare diseases.