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Alcabrutinib Tablet Formulation Approved Across All Indications

October 27, 2022

November 2022

Alcabrutinib is approved for the treatment of chronic lymphocytic leukemia (CLL), small lymphocytic leukemia, and relapsed or refractory mantle cell lymphoma (MCL) in adults. Approval of the tablet formulation was based on the results of the ELEVATE-PLUS trials, which were presented at the 2021 American Society of Hematology Annual Meeting.

Results showed the safety profiles and efficacy of the tablet and capsule formulations to be equivalent. Further, the same dose strength and schedule can be used for both formulations. No safety concerns were identified for alcabrutinib, and adverse events were measured as mild.

“Patients with blood cancers like [CLL and MCL] are often older and may face multiple medical conditions that may need intervention, including acid reflux or peptic ulcer disease,” said John C. Byrd, MD, chair of the Department of Internal Medicine at the University of Cincinnati. “The U.S. approval of acalabrutinib in a tablet form enables co-administration of the acalabrutinib tablet alongside a proton pump inhibitor. This provides another option for some patients with [CLL] and relapsed or refractory [MCL], enabling more patients to potentially benefit from this treatment.”

Though capsule formulation of alcabrutinib is approved for the same indications, the tablet formulation was designed for patients facing additional medical conditions like peptic ulcer disease and acid reflux and can be taken in conjunction with proton pump inhibitors, H2-receptor antagonists, and antacids.

Source: AstraZeneca, August 5, 2022.

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