AstraZeneca cancer drug Calquence's tablet form gets FDA approval
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AstraZeneca (NASDAQ:AZN) said on Aug. 5 that the U.S. Food and Drug Administration (FDA) approved a new tablet formulation of Calquence (acalabrutinib) for all current uses.
The approval covers all indications, including adult patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) and for patients with relapsed or refractory mantle cell lymphoma (MCL), which is approved under accelerated approval based on overall response rate.

The British drugmaker said that the FDA decision was backed by data from trials called ELEVATE-PLUS.
The company added that the studies showed that Calquence capsule and tablet formulations are bioequivalent, suggesting 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, AstraZeneca (AZN) noted.