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 lymphoma.

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 michael.dabaie@wsj.com

 

(END) Dow Jones Newswires

November 21, 2019 11:28 ET (16:28 GMT)

Copyright (c) 2019 Dow Jones & Company, Inc.
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