31 October 2017 - The U.S. FDA today granted accelerated approval to Calquence (acalabrutinib) for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy. 

“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. “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 FDA granted this application priority review and breakthrough therapy designations. Calquence also received orphan drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.

Read FDA press release