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Weekly Digest - November 2024
12 Nov 2024: AstraZeneca, Daiichi withdraw lung cancer approval application for Enhertu follow-up and try again
- Daiichi Sankyo and AstraZeneca have withdrawn their FDA application for Dato-DXd in non-squamous non-small cell lung cancer (NSCLC) to pursue a new indication based on FDA feedback
- The initial application for Dato-DXd was based on phase 3 TROPION-Lung01 trial data, which showed median progression-free survival (PFS) of 5.6 months compared to 3.7 months for docetaxel
- Concerns arose when overall survival (OS) results favored Dato-DXd but lacked statistical significance, with OS figures of 14.6 months for Dato-DXd and 12.3 months for docetaxel in the non-squamous subgroup
- The new application targets EGFR-mutated NSCLC and is based on the ongoing phase 2 TROPION-Lung05 trial, which has enrolled 137 patients
