FDA Approves Acalabrutinib Tablet Formulation for All Approved Indications


Based on overall response rate, acalabrutinib in tablet form is now FDA approved for all approved indications, enabling co-administration alongside a proton pump inhibitor.

The FDA granted accelerated approval to acalabrutinib (Calquence; AstraZeneca) for all current indications, including adult patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and relapsed or refractory mantle cell lymphoma (MCL).

“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 to Cincinnati, in a press release.

To combat these gastrointestinal (GI) conditions, acalabrutinib can be taken with proton pump inhibitors (PPIs), antacids, H2-receptor antagonists, or other gastric acid-reducing agents. At the proper dosing, the tablet formulation was measured as being safe and effective, aligning with researcher goals and expectations.

“The US approval of acalabrutinib in a tablet form enables co-administration of the acalabrutinib tablet alongside a [PPI]. This provides another option for some patients with [CLL] and [MCL], enabling more patients to potentially benefit from this treatment,” explained Byrd in the press release.

Acalabrutinib is a bruton tyrosine kinase (BKT) inhibitor, which binds to BTK, causing B-cell proliferation and chemotaxis in CLL and MCL, inhibiting further growth and activity. Available in the United States, acalabrutinib can now be administered in the capsule or tablet form based on the overall response rate observed in clinical trials.

The most prevalent type of adult leukemia, CLL can result in anemia, infection, and bleeding. In 2019, there were more than 100,000 cases globally, with more than 20,000 diagnoses expected in the United States in 2022. On the other hand, MCL is a more uncommon sybtype of B-cell non-Hodgkin lymphoma that has an average 4000 yearly diagnoses in the United States.

Acalabrutinib was evaluated in the ELEVATE-PLUS trials. Among 116 patients in 3 phase I, open-label, single-dose, cross-over studies, investigators established bioequivalence between 100 mg of acalabrutinib tablets and capsules when given with a PPI.

Although the tablets are not yet licensed in the EU, acalabrutinib capsules are approved in the EU and in other countries worldwide to treat CLL and SLL. Capsules are also approved to treat MCL patients who have gone through one prior therapy.

Patients may experience fatal or serious infections on acalabrutinib . Other adverse effects (AEs) include hemmorhage, cytopenias, and atrial fibrillation and flutter. The most common AEs, reported by less than 20% of patients with MCL are anemia, headache, fatigue, and bruising.

Currently, acalabrutinibis also being evaluated in more than 20 AstraZeneca-sponsored trials for the treatment of multiple B-cell blood cancers.

“Today’s approval of the new [acalabrutinib] tablet formulation will offer physicians and patients increased flexibility when devising treatment plans for [CLL] and [MCL]. 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,” explained Dave Fredrickson, executive vice president, Oncology Business Unit, at AstraZeneca, in a press release.


AstraZeneca. CALQUENCE® (acalabrutinib) tablet formulation approved in the US across current indications. Wilmington, DE: AstraZeneca; Aug 5, 2022. Accessed on Aug 8, 2022. https://www.businesswire.com/news/home/20220805005419/en/CALQUENCE®-acalabrutinib-tablet-formulation-approved-in-the-US-across-current-indications

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