LONDON (Reuters) – AstraZeneca said it had voluntarily withdrawn from the European Medicines Authority on Tuesday the group’s application to obtain marketing authorization for its experimental targeted therapy, intended to treat a certain type of lung cancer.
Datopotamab deruxtecan (Dato-DXd), developed with the Japanese group Daiichi Sankyo, received breakthrough therapy designation from the United States Drug Authority (FDA) earlier this month, for its results in the treatment of a certain type of lung cancer, where other drugs had failed.
AstraZeneca said in a statement that the decision comes after the group took note of comments from the Committee for Medicinal Products for Human Use (CHMP), the European Medicines Agency. Its application was based on data collected during the late-stage TROPION-Lung01 study.
The results of that trial have hit AstraZeneca stock several times, most recently in September, when data showed the drug did not significantly improve patients’ chances of survival.
The treatment belongs to a promising group known as antibody-drug conjugates, which combine monoclonal antibodies capable of identifying cancer cells with a cytotoxic chemotherapeutic payload.
(Maggie Fick; Pauline Foret, edited by Augustin Turpin)
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