AstraZeneca’s Calquence Tablet Formulation Gains FDA Approval


By Anthony O. Goriainoff

AstraZeneca PLC said Friday that the tablet formulation of its Calquence lymphoma treatment has been approved by the US Food and Drug Administration for all current indications.

The British-Swedish pharma giant said the approval was based on the results of the Elevate-Plus trials where the capsule and tablet formulations of Calquence were shown to be bioequivalent, indicating that the same efficacy and safety can be expected with the same dosage strength and timing.

The company said Calquence, or acalabrutinib, has also been approved as a capsule formulation for the same indications as the tablet in the US and many other countries around the world.

“Today’s approval of the new Calquence tablet formulation will provide physicians and patients with greater flexibility when designing treatment plans for chronic lymphocytic leukemia and mantle cell lymphoma. This new option is the result of our focus on understanding the wants and needs of this community and providing targeted solutions for addressing them,” the company said.

Shares at 11:19 GMT rose 90 pence, or 0.8%, to 10,810 pence.

Write to Anthony O. Goriainoff at anthony.orunagoria[email protected]


Comments are closed.