Datopotamab deruxtecan application in the EU for patients with advanced non-squamous non-small sell lung cancer voluntarily withdrawn

Daiichi Sankyo

24 December 2024 - Daiichi Sankyo and AstraZeneca have voluntarily withdrawn the marketing authorisation application in the EU for datopotamab deruxtecan for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer based on the TROPION-Lung01 Phase 3 trial.

The decision to withdraw the marketing authorisation application was informed by feedback from the CHMP of the EMA.

Read Daiichi Sankyo press release

Michael Wonder

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Michael Wonder

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Cancer , Medicine , Europe , Dossier , Withdrawal