FDA Grants Supplemental Approval to AstraZeneca's Calquence
By Michael Dabaie
The U.S. Food and Drug Administration granted supplemental
approval to AstraZeneca PLC (AZN) for Calquence to treat adults
with chronic lymphocytic leukemia or small lymphocytic
This new approved indication for Calquence provides a new
treatment option for patients with CLL or SLL as an initial or
subsequent therapy, the FDA said.
The FDA said the approval was part of Project Orbis, a
collaboration with the Australian Therapeutic Goods Administration
and Health Canada. Project Orbis provides a framework for
concurrent submission and review of oncology drug applications
among the FDA's international partners.
AstraZeneca ADRs were recently up 1% to $47.47.
Write to Michael Dabaie at email@example.com
(END) Dow Jones Newswires
November 21, 2019 11:28 ET (16:28 GMT)
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