Partners Daiichi Sankyo (TYO: 4568) and AstraZeneca (AZ, NASDAQ: AZN) have jointly announced the voluntary withdrawal of the marketing authorization application (MAA) in the European Union for their co-developed drug, datopotamab deruxtecan (Dato-DXd). This decision pertains to the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (nsq-NSCLC) and follows feedback from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
Ongoing Review for Breast Cancer Indication
Despite the withdrawal for the lung cancer indication, another MAA for datopotamab deruxtecan to treat hormone receptor (HR)-positive, HER2-negative metastatic breast cancer, based on the TROPION-Breast01 Phase III trial, remains under review in the EU. This highlights the continued potential for the drug in other therapeutic areas.
Trial Results and Previous Withdrawals
According to the press release, the TROP2-directed DXd antibody drug conjugate (ADC) demonstrated statistically significant improvement in progression-free survival (PFS) during the global, randomized, multicenter, open-label Phase III trial. However, it failed to meet the dual primary endpoint of overall survival (OS) when compared to docetaxel in adult patients with locally advanced or metastatic nsq-NSCLC. Previously, Daiichi Sankyo and AstraZeneca had also withdrawn a Biologic License Agreement (BLA) in the US for the drug in advanced or metastatic nsq-NSCLC patients, opting instead to seek accelerated approval for the drug in previously treated advanced EGFR mutant NSCLC.-Fineline Info & Tech
