Posted by Michael Wonder on 12 Nov 2024
Datopotamab deruxtecan new BLA submitted for accelerated approval in the US for patients with previously treated advanced EGFR mutated non-small cell lung cancer
12 November 2024 - Daiichi Sankyo and AstraZeneca’s new application is based on the TROPION-Lung05 Phase 2 trial and supported by data from additional trials including TROPION-Lung01.
Daiichi Sankyo and AstraZeneca have submitted a new biologics license application for accelerated approval in the US for datopotamab deruxtecan for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFR mutated) non-small cell lung cancer who have received prior systemic therapies, including an EGFR directed therapy.
The companies have voluntarily withdrawn the biologics license application in the US for datopotamab deruxtecan for patients with advanced or metastatic non-squamous non-small cell lung cancer based on the TROPION-Lung01 phase 3 trial.
