AstraZeneca & Daiichi Sankyo Reassess EU Application for Innovative Lung Cancer Therapy

AstraZeneca and Daiichi Sankyo have decided to voluntarily withdraw their marketing authorization application (MAA) in the European Union for datopotamab deruxtecan (Dato-DXd), a TROP2-directed DXd antibody-drug conjugate (ADC), for treating adults with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC). The decision follows feedback from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).

Continuing Efforts for Lung Cancer Treatments

While the withdrawal represents a temporary step back, the companies reaffirm their dedication to bringing datopotamab deruxtecan to patients in the EU who might benefit. The TROPION-Lung01 Phase III trial, which was central to the MAA, is part of a broader development strategy. AstraZeneca and Daiichi Sankyo are pursuing seven pivotal trials to evaluate datopotamab deruxtecan across various lung cancer settings.

Other Applications Under Review

In addition to their focus on lung cancer, the application for datopotamab deruxtecan in the treatment of hormone receptor (HR)-positive, HER2-negative metastatic breast cancer, based on the TROPION-Breast01 Phase III trial, is still under review in the EU.

About Datopotamab Deruxtecan

Discovered by Daiichi Sankyo, datopotamab deruxtecan is a specially designed ADC targeting the TROP2 protein. Its DXd payload is intended to precisely deliver cytotoxic treatment to cancer cells while minimizing harm to surrounding healthy tissue. AstraZeneca and Daiichi Sankyo continue to jointly develop this innovative therapy to maximize its potential in addressing various cancer types.

This step illustrates AstraZeneca and Daiichi Sankyo's careful consideration of regulatory pathways while maintaining a robust commitment to advancing cancer treatments.