FDA Approves Acalabrutinib for CLL, SLL, R/R MCL

The U.S. Food and Drug Administration (FDA) has approved the new tablet formulation of acalabrutinib for all current indications, including adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and for patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL).

The approval is based on results from the ELEVATE-PLUS trials presented during the American Society of Hematology Annual Meeting & Exposition in December 2021.

The drug, manufactured by AstraZeneca, is also approved as a capsule formulation for the same indications as the tablet in the United States and in other countries.

In the trials, the capsule and tablet were demonstrated to be bioequivalent, indicating the same efficacy and safety profile can be expected with the same dosing strength and schedule, according to a press release by the company. The majority of observed adverse events in these studies were mild with no new safety concerns reported.

Source: Business Wire press release via AstraZeneca, August 2022