AstraZeneca: registration withdrawn in Europe
(CercleFinance.com) - AstraZeneca and its Japanese partner Daiichi Sankyo on Tuesday announced that they had withdrawn their application for registration of Dato-DXd in the treatment of non-small-cell lung cancer.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.
Copyright (c) 2024 CercleFinance.com. All rights reserved.
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.
Copyright (c) 2024 CercleFinance.com. All rights reserved.