FDA Grants Accelerated Approval to Acalabrutinib for Mantle Cell Lymphoma

The U.S. Food and Drug Administration granted accelerated approval to the kinase inhibitor acalabrutinib for adults with previously treated mantle cell lymphoma (MCL).

The approval was based on findings from the single-arm, phase II ACE-LY-004 study, which included 124 patients with MCL who had received at least one prior treatment (median = 2 therapies; range = 1-5 therapies). Patients received acalabrutinib 100 mg orally twice-daily. After a median follow-up of 15.2 months (range not provided), the objective response rate was 81 percent (95% CI 73-87), including 40 percent who achieved a complete response (CR) and 41 percent who achieved a partial response (PR). The median time to best response was 1.9 months (range not provided), and the median duration of response had not been reached (20+ months).

Adverse events (AEs) associated with acalabrutinib include headache, diarrhea, bruising, fatigue, myalgia, anemia, thrombocytopenia, and neutropenia. Serious AEs include hemorrhage, infection, and atrial fibrillation. Second primary malignancies (SPMs) were also reported. Dose reductions related to AEs were required in 1.6 percent of patients, and 6.5 percent of patients discontinued treatment because of AEs.

Acalabrutinib previously received priority review, breakthrough-therapy, and orphan-drug designations for this indication.

Source: U.S. Food and Drug Administration news release, October 31, 2017.