07:12 AM EST, 11/12/2024 (MT Newswires) -- AstraZeneca ( AZN ) and Daiichi Sankyo said Tuesday they have submitted a new Biologics License Application for accelerated approval in the US for datopotamab deruxtecan to treat adult patients with advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer.

The companies voluntarily withdrew the BLA for datopotamab deruxtecan for the treatment of advanced or metastatic nonsquamous non-small cell lung cancer based on the Tropion-Lung01 phase 3 study, they added, after receiving feedback from the US Food and Drug Administration.

The new application is based on results from the Tropion-Lung05 phase 2 study and data from the Tropion-Lung01 phase 3 and Tropion-PanTumor01 phase 1 trials, the companies said.

AstraZeneca ( AZN ) and Daiichi Sankyo are jointly developing datopotamab deruxtecan, which was discovered by the latter.

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