The drug, Calquence, is used to combat Mantle cell lymphoma after a prior treatment has failed. It is a kinase inhibibitor that blocks an enzyme the cancer needs to multiply and spread.
“Mantle cell lymphoma is a particularly aggressive cancer,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence. “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 drug was approved using the FDA’s accelerated approval pathway.
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