- AstraZeneca
- 24 December 2024 07:33:55
Source: Sharecast
The filing for datopotamab deruxtecan (Dato-DXd), jointly developed by AstraZeneca and Japanese pharma group Daiichi Sankyo, was voluntarily withdrawn after feedback on the Tropion-Lung01 trial from the Committee for Medicinal Products for Human Use of the European Medicines Agency, the company said on Tuesday.
The news comes despite primary results from the trial showing that datopotamab deruxtecan demonstrating a statistically significant improvement in progression-free survival over standard chemotherapy.
"AstraZeneca and Daiichi Sankyo will continue to work to bring datopotamab deruxtecan to patients with lung cancer in the EU who can benefit and are committed to unlocking the potential of this medicine in lung cancer through our robust clinical development programme which includes seven pivotal trials in various lung cancer settings," AstraZeneca said in a statement.
The companies' ongoing EU application for datopotamab deruxtecan for the treatment of hormone receptor-positive, HER2-negative metastatic breast cancer based on the TROPION-Breast01 Phase III trial still remains under review.