AstraZeneca: registration withdrawn in Europe

(CercleFinance.com) - AstraZeneca and its Japanese partner Daiichi Sankyo on Tuesday announced that they had withdrawn their application for registration of Dato-DXd in the treatment of non-small-cell lung cancer.


In a press release, the groups backed up their decision with exchanges with the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).

A Phase III clinical trial showed that Dato-DXd delivered a 'statistically significant' improvement in progression-free survival for patients treated with the anti-cancer drug docetaxel.

As for AstraZeneca and Daiichi Sankyo's planned registration of Dato-DXd in the treatment of HER2-negative metastatic breast cancer (HR)-positive, the two companies state that this is still under review.

This unexpected development in the marketing of the antibody-conjugate did not prevent AstraZeneca shares from gaining 0.5% on Tuesday morning on the London Stock Exchange.

Datopotamab deruxtecan (Dato-DXd) recently received "breakthrough therapy" designation from the US FDA in non-small cell lung cancer.


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