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Daiichi Sankyo and AstraZeneca Report the US FDA Approval of Datroway for Advanced EGFR-Mutated NSCLC

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  • The US FDA has approved Datroway (datopotamab deruxtecan-dlnk; 6 mg/kg) for adults with locally advanced or metastatic EGFR-mutated NSCLC previously treated with EGFR therapy & Pt CT
  • Approval was based on the global P-II (TROPION-Lung05) trial results (n=137) and supported by data from the P-III (TROPION-Lung01) trial (n=590), which showed a 45% confirmed ORR (n=114) with previously treated locally advanced or metastatic EGFR-mutated NSCLC, with 4.4% complete and 40% partial responses. mDoR was 6.5 mos.
  • Daiichi Sankyo & AstraZeneca are testing Datroway alone or with osimertinib in advanced EGFR-mutated NSCLC in the P-III TROPION-Lung14 and Lung15 trials

Ref: Daiichi Sankyo | Image: Daiichi Sankyo| Press Release

Related News:- Daiichi Sankyo and AstraZeneca Report Topline P-III (DESTINY-Breast11) Trial Data of Neoadjuvant Enhertu for HER2+ Early-Stage Breast Cancer

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