Lung cancer: why AstraZeneca withdrew its drug application from the European Medicines Authority ?

AstraZeneca withdraws EU application for lung cancer drug. ILLUSTRATION imageBROKER.com – imageBROKER/JAQUE DA SILVA

AstraZeneca said it had voluntarily withdrawn its application to the European Medicines Authority on Tuesday for marketing authorisation for its experimental targeted therapy, which is intended to treat a certain type of lung cancer.

Datopotamab deruxtecan (Dato-DXd), developed with Japan’s Daiichi Sankyo, received breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) earlier this month for its success in treating a type of lung cancer where other drugs had failed.

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No improvement in survival

AstraZeneca said in a statement that the decision comes after the company received comments from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). Its application was based on data collected from the late-stage TROPION-Lung01 study.

The results from that trial have hit AstraZeneca’s stock several times, most recently in September when data showed the drug didn’t significantly improve patients’ chances of survival.

The treatment belongs to a promising group known as antibody-drug conjugates, which combine monoclonal antibodies that can identify cancer cells with a cytotoxic chemotherapy payload.