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AstraZeneca's Datroway Wins U.S. Approval for EGFR-Mutated Lung Cancer
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AstraZeneca's Datroway Wins U.S. Approval for EGFR-Mutated Lung Cancer
Jun 23, 2025 2:56 PM

05:44 PM EDT, 06/23/2025 (MT Newswires) -- AstraZeneca ( AZN ) said its Datroway drug received accelerated US approval to treat adults with locally advanced or metastatic non-small cell lung cancer harboring epidermal growth factor receptor mutations, following prior EGFR-directed therapy and platinum-based chemotherapy.

The approval follows the Food and Drug Administration's priority review and breakthrough therapy designation, based on phase 2 and 3 data showing a 45% objective response rate and a median duration of response of 6.5 months, the company said Monday in a statement.

Datroway is being developed and commercialized by Daiichi Sankyo and AstraZeneca ( AZN ).

AstraZeneca ( AZN ) owes $45 million to Daiichi Sankyo as a milestone payment following the US approval.

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