FDA Okays Tablet Version of Acalabrutinib for All Indications

The US Food and Drug Administration has approved AstraZeneca’s new tablet formulation of acalabrutinib (Calquence) for all current indications of the capsule version.

These include adult patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and relapsed or refractory mantle cell lymphoma (MCL).

Approval of the tablet formulation of the selective Bruton’s tyrosine kinase inhibitor was based on the ELEVATE-PLUS trials, which showed bioequivalence with the capsule. The tablet had the same efficacy and safety profile with the same dosing strength and schedule, AstraZeneca said in a press release.

The benefit of the tablet formulation is that patients with acid reflux and other problems can take it with proton pump inhibitors, antacids, and H2-receptor antagonists, the company noted.

M. Alexander Otto is a physician assistant with a master’s degree in medical science. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape and is an MIT Knight Science Journalism fellow. Email: [email protected]e.com.

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