The U.S. Food and Drug Administration Wednesday granted accelerated approval for Calquence (ingredient: acalabrutinib) to treat adults with mantle cell lymphoma who had previous treatment.
Mantle cell lymphoma is a rare and fast-growing type of non-Hodgkin lymphoma that affects the lymph system. This type of cancer affects around three to 10 percent of all non-Hodgkin lymphoma cases in the U.S., according to the National Cancer Institute.
“Mantle cell lymphoma is a particularly aggressive cancer,” said Richard Pazdur, 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.”
AstraZeneca’s Calquence is a kinase inhibitor that blocks the enzyme used by cancer cells to multiply and spread, the FDA said. Clinical data from a single-arm trial with 124 mantle cell lymphoma patients who had received at least one prior treatment demonstrated 81 percent to show a complete or partial response (40 percent complete, 41 percent partial response).
AstraZeneca obtained the drug from developer Acerta in a deal that exceeded $4 billion in 2015.
The drug had previously gained priority review, breakthrough therapy, and orphan drug designation, the agency said.
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