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.
John C. Byrd, M.D.
“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.
Using the 'Pathway' Approach to Shorten the Time Between Cancer Diagnosis and Treatment
November 16th 2022In this episode of Tuning In to the C-Suite, Briana Contreras, editor with Managed Healthcare Executive spoke with Dr. Yuri Fesko, oncologist and vice president of Medical Affairs at Quest Diagnostics. In the conversation, Dr. Fesko addressed the ongoing issue of long gaps of times between receiving a diagnosis for a type of cancer and finally getting the treatment for it. Dr. Fesko shared the benefits a number of sectors receive when treating patients sooner and the steps to get there.
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