FDA Approves Calquence for Mantle Cell Lymphoma

Astra Zeneca is seen on a medication package in a pharmacy in London Britain

Astra Zeneca is seen on a medication package in a pharmacy in London Britain

Calquence (acalabrutinib) was granted an accelerated approval by the FDA to treat adult patients with mantle cell lymphoma (MCL) following at least one prior therapy.

"Mantle cell lymphoma is a particularly aggressive cancer", Richard Pazdur, M.D., 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, said in a statement.

Mantle cell lymphoma is a rare and fast-growing type of non-Hodgkin lymphoma and, according to the National Cancer Institute at the National Institutes of Health, represents 3 to 10 percent of all non-Hodgkin lymphoma cases in the U.S. Mantle cell lymphoma is a cancer of the lymph system, which is part of the body's immune system and is made up of lymph tissue, lymph nodes, the spleen, thymus, tonsils and bone marrow.

Calquence is a kinase inhibitor that works by blocking an enzyme needed by the cancer to multiply and spread. "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". The approval was based on objective response rates (ORR) in a single-arm trial.

Under the accelerated approval program, full approval for acalabrutinib is contingent on findings from confirmatory trials. The investigators assessed how many patients experienced a complete or partial tumor shrinkage. Currently, the phase III ACE-LY-308 clinical trial is evaluating acalabrutinib in combination with bendamustine and rituximab (BR) versus placebo plus BR for patients with untreated MCL.

The most common adverse events (AEs) of any grade were anemia (46 percent), thrombocytopenia (44 percent), headache (39 percent), neutropenia (36 percent), diarrhea (31 percent), fatigue (28 percent), myalgia (21 percent) and bruising (21 percent), which is a known class effect for BTK inhibition. Serious side effects reported for acalabrutinib include hemorrhage, atrial fibrillation, and infections; there have also been reports of second primary malignancies.

For more from the FDA, including applications, designations and approvals, follow Rare Disease Report on Facebook and Twitter.

The FDA granted the accelerated approval of Calquence to AstraZeneca Pharmaceuticals LP.

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