US FDA Approves AstraZeneca New Tablet Formulation of Calquence

The US FDA approved the new tablet formulation of Calquence by AstraZeneca in the United States for all current indications, including patients with chronic lymphocytic leukaemia (CLL), small lymphocytic lymphoma (SLL), and patients with relapsed mantle cell lymphoma.

The approval by the US FDA was based on results from the ELEVATE-PLUS trials presented at the 63^rd American Society of Hematology (ASH) Annual Meeting & Exposition in December 2021. In the trials, results showed the Calquence capsule and tablet formulations, and indicated the same efficacy and safety profile could be expected with the same schedule and dosing strength.

The US approval of the formulation in a tablet form enables co-administration of the acalabrutinib tablet along with a proton pump inhibitor. This also provides another option for some patients with chronic lymphocytic leukaemia, and relapsed mantle cell lymphoma, enabling more patients to benefit from this treatment.

Dave Fredrickson, executive vice president of the oncology business unit at AstraZeneca, said the approval of the new Calquence tablet formulation will offer patients and physicians increased flexibility when devising treatment plans for mantle cell lymphoma and chronic lymphocytic leukaemia.

He also said this new treatment option is a result of their focus on understanding the wants, and needs of the community, and providing solutions based on their treatment focusing on the patients. Calquence is also approved as a capsule formulation for similar indications as tablet in the United States.