FDA Approves Tablet Form of Calquence

The tablet form has the same safety and efficacy as the capsule formulation and allows it to be administered with gastric-reducing therapies.

The FDA has approved a tablet formulation of AstraZeneca’s Calquence (acalabrutinib) for all current indications, including adult patients with chronic lymphocytic leukemia, small lymphocytic lymphoma and for patients with relapsed or refractory mantle cell lymphoma, which is approved under accelerated approval based on overall response rate.

“Patients with blood cancers like chronic lymphocytic leukemia and mantle cell lymphoma are often older and may face multiple medical conditions that may need intervention, including acid reflux or peptic ulcer disease,” John C. Byrd, M.D., chair of the Department of Internal Medicine at the University of Cincinnati, said in a press release. The U.S. approval of acalabrutinib in a tablet form enables co-administration of with a proton pump inhibitor.”

The approval was based on results from the ELEVATE-PLUS trials, which showed the Calquence capsule and tablet formulations are bioequivalent, indicating the same efficacy and safety profile can be expected with the same dosing strength and schedule. The tablet can be taken with gastric acid-reducing agents, including proton pump inhibitors, antacids and H2-receptor antagonists. The majority of observed adverse events in these studies were mild with no new safety concerns identified.