The FDA granted a supplemental approval to acalabrutinib for the treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Acalabrutinib was previously approved by the FDA for the treatment of mantle cell lymphoma.
This new indication for CLL/SLL was based on results from two randomized clinical trials that compared acalabrutinib with other standard treatments: ELEVATE-TN, which enrolled 535 patients with treatment-naïve CLL, and ASCEND, which enrolled 310 patients with previously treated CLL. In both trials, participants who received acalabrutinib had longer progression-free survival, compared with the standard treatment arms.
The most common adverse events related to acalabrutinib were anemia, neutropenia, upper respiratory tract infection, thrombocytopenia, headache, diarrhea, and musculoskeletal pain. The approval letter also noted that patients should be monitored for symptoms of arrhythmia, based on the risk of atrial fibrillation and atrial flutter observed in clinical trials.
This approval decision was made as part of Project Orbis, a collaboration with the Australian Therapeutic Goods Administration and Health Canada. “The FDA’s Project Orbis provides a framework for concurrent submission and review of oncology drug applications among the FDA’s international partners,” explained Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research. “We are pleased to continue working alongside our Australian and Canadian colleagues to facilitate new treatment options for patients and the FDA looks forward to working with other countries in future application reviews.” Acalabrutinib has been approved for mantle cell lymphoma in Canada and Australia, but not for CLL.
This review also used the FDA’s Real-Time Oncology Review program, through which the FDA can access clinical trial data before the information is formally submitted to the agency.