AstraZeneca, Daiichi's Enhertu Approved by the FDA for Lung Cancer Treatment
12 Agosto 2022 - 3:53AM
Dow Jones News
By Michael Susin
AstraZeneca PLC and Daiichi Sankyo Co. have said that their
antibody drug Enhertu has been approved by the U.S. Food and Drug
Administration to treat adult patients with metastatic non-small
cell lung cancer, whose tumours have activating mutations, and have
received previous therapy.
The pharmaceutical giant said the decision came based on the
response rate of 57.7% in patients with HER2-mutant disease from a
Phase 2 trial.
"Continued approval for this indication may be contingent upon
verification and description of clinical benefit in a confirmatory
trial," AstraZeneca said.
Enhertu is being jointly developed and commercialized by
AstraZeneca and Daiichi Sankyo.
Write to Michael Susin at michael.susin@wsj.com
(END) Dow Jones Newswires
August 12, 2022 02:38 ET (06:38 GMT)
Copyright (c) 2022 Dow Jones & Company, Inc.
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