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)

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