AstraZeneca withdraws EU submission for lung cancer drug

24 December 2024

AstraZeneca (LSE: AZN) and development partner Daiichi Sankyo (TYO: 4568) have withdrawn a marketing authorization application for datopotamab deruxtecan (Dato-DXd) in lung cancer.

The firms had submitted for approval to market the antibody-drug conjugate (ADC) for the treatment of a relatively broad population of non-squamous non-small cell lung cancer (NSCLC) patients, but reversed course after feedback from the agency’s scientific panel.

The application was based on results from the Phase III TROPION-Lung01 trial, which showed a progression-free survival benefit for Dato-DXd over chemotherapy in patients with non-squamous NSCLC. However, the study failed to demonstrate a statistically-significant overall survival advantage, a key benchmark for regulatory approval.

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