Accelerated approval was granted today by the U.S. Food and Drug Administration (FDA) to Calquence (acalabrutinib) for the treatment of adults with mantle cell lymphoma (MCL) who have received at minimum one previous form of therapy.
Under the Accelerated Approval pathway, the FDA may approve drugs which exhibit clinical benefit to patients with severe conditions with an unmet medical need.
MCL is a rare, quickly growing variation of non-Hodgkin lymphoma (NHL), and per the National Institutes of Health (NIH)
, represents between 3 and 10% of all non-Hodgkin lymphoma cases in the United States. In MCL, cancerous B-cells come within a region of the lymph node referred to as the mantle zone. While the disease itself spreads slowly, it is typically widespread to the lymph nodes, bone marrow and other organs by the time it is discovered.
It’s not uncommon for patients with MCL to be at an increased risk for gastrointestinal issues, like obstruction, intussusception, and multiple intestinal polyps, in addition to very high counts of white blood cells.
“Mantle cell lymphoma is a particularly aggressive cancer,” said 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 in a press release
. “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.”
Today’s approval of Calquence, a kinase inhibitor that operates by blocking the enzyme necessary for cancer types to multiply and spread, was based on data from a single-arm trial that evaluated 124 patients with MCL who had received at least one prior treatment. In the study, success was measured by how many patients experienced complete or partial shrinkage of their tumors after treatment, or overall response rate (ORR).
Results of the trial concluded that an astounding 81% of all patients had a complete (40%) or partial response (41%).
Common side effects of Calquence include headache, diarrhea, bruising, fatigue, and muscle pain, as well as reduced levels of red blood cells (anemia), platelets (thrombocytopenia) and neutrophils (neutropenia) in the blood. Serious side effects include bleeding (hemorrhage), infections and irregular heartbeat (atrial fibrillation).
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