AstraZeneca's Calquence Tablet Formulation Gets FDA Approval
05 August 2022 - 09:59PM
Dow Jones News
By Anthony O. Goriainoff
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.
Shares at 1119 GMT were up 90 pence, or 0.8%, at 10,810
pence.
Write to Anthony O. Goriainoff at
anthony.orunagoriainoff@dowjones.com
(END) Dow Jones Newswires
August 05, 2022 07:44 ET (11:44 GMT)
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