AstraZeneca PLC said Friday that its lymphoma treatment Calquence's tablet formulation has been approved by the U.S. Food and Drug Administration for all current indications.
The Anglo-Swedish pharmaceutical giant said the approval was based on results from the Elevate-Plus trials where it was shown that Calquence's capsule and tablet formulations are bioequivalent, indicating the same efficacy and safety profile can be expected with the same dosing strength and schedule.
The company said Calquence, or acalabrutinib, was also approved as a capsule formulation for the same indications as the tablet in the U.S. and in many other countries around the world.
"Today's approval of the new Calquence tablet formulation will offer physicians and patients increased flexibility when devising treatment plans for chronic lymphocytic leukaemia 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," the company said.
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