BRIEF—Calquence tablet formulation approved in the USA

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

Results from the ELEVATE-PLUS trials showed the Calquence capsule and tablet formulations are bioequivalent, indicating the same efficacy and safety profile can be expected with the same dosing strength and schedule.

Dave Fredrickson, executive vice president, oncology business unit, AstraZeneca, said: “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.”

Calquence is also approved as a capsule formulation for the same indications as the tablet in many other countries worldwide.