FDA Approves New Tablet Form for Acalabrutinib

Acalabrutinib’s new tablet formulation has been granted FDA approval for all current indications, including adult patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, and relapsed or refractory mantle cell lymphoma.

The FDA has granted approval to acalabrutinib’s (Calquence) new tablet formulation for all current indications, including adult patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and for relapsed or refractory mantle cell lymphoma (MCL).1

This approval decision was made based on the results of the ELEVATE-PLUS trials, which were presented at the 63rd American Society of Hematology Annual Meeting & Exposition in December 2021.2

Results from ELEVATE-PLUS showed the acalabrutinib capsule and tablet formulations are bioequivalent, indicating that both have the same efficacy and safety profile with the same dosing strength and schedule. It is noted that the tablet can be taken with gastric acid-reducing agents, including proton pump inhibitors (PPIs), antacids, and H2-receptor antagonists. Adverse events and safety were mild in these studies and no new safety signals were identified.

“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. The US 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 chronic lymphocytic leukemia and relapsed or refractory mantle cell lymphoma, enabling more patients to potentially benefit from this treatment,” said John C. Byrd, MD, chair of the Department of Internal Medicine at the University of Cincinnati, in the press release.

The ELEVATE-PLUS trials consist of 3 phase 1, open-label, single-dose, cross-over studies conducted in 116 patients. The trials established bioequivalence between 100 mg acalabrutinib tablets and 100 mg acalabrutinib capsules, evaluated the PPI effect of acalabrutinib tablets administered in the presence vs the absence of PPI rabeprazole (Aciphex), and investigated the effect of food by comparing acalabrutinib tablets administered with a high-fat diet vs a fasted diet.

The acalabrutinib capsule formulation is also approved for the same indications as the tablet in the United States and other nations.

Acalabrutinib is a next-generation, selective inhibitor of bruton’s tyrosine kinase (BTK) which binds covalently to BTK, inhibiting its activity. In B cells, BTK signaling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis and adhesion.1

“Today’s approval of the new Calquence tablet formulation will offer physicians and patients increased flexibility when devising treatment plans for chronic lymphocytic leukemia and mantle cell lymphoma. This new option is a result of our focus on understanding the wants and needs of this community and providing patient-focused solutions for their treatment,” said Dave Fredrickson, executive vice president of the Oncology Business Unit at AstraZeneca, in the press release.

Kemp A. Calquence tablet formulation approved in the US across current indications. Press release. AstraZeneca; August 5, 2022. Accessed August 5, 2022. https://bit.ly/3P42p9r
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