FRIDAY, Nov. 22, 2019 -- The U.S. Food and Drug Administration has granted supplemental approval to Calquence (acalabrutinib) for treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), the agency announced Thursday.
Calquence was initially approved in 2017 for treatment of adults with previously treated mantle cell lymphoma. It is now approved as a new treatment option or as an initial or subsequent therapy for adults with CLL or SLL. The latest approval of Calquence is part of Project Orbis, a collaboration among the FDA, the Australian Therapeutic Goods Administration, and Health Canada. Through Project Orbis, oncology drug applications can be concurrently submitted for review among the FDA and its international partners, according to Richard Pazdur, M.D., director of the FDA Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA Center for Drug Evaluation and Research.