AstraZeneca's Datopotamab Deruxtecan Applications Validated In EU For Lung Cancer, Breast Cancer

(RTTNews) - AstraZeneca Plc. (AZN.L, AZN) and Daiichi Sankyo (DSKYF.PK) said that the European Medicines Agency or EMA has validated two marketing authorisation applications for the companies' datopotamab deruxtecan or Dato-DXd in two types of cancer.

The first marketing authorisation application is for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who require systemic therapy following prior treatment.

The other marketing authorisation application is for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have progressed on and are not suitable for endocrine therapy and received at least one additional systemic therapy.

The validations confirm the completion of the applications and commence the scientific review process by the EMA's Committee for Medicinal Products for Human Use.

Datopotamab deruxtecan is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by AstraZeneca and Daiichi Sankyo.

AstraZeneca and Daiichi Sankyo noted that additional regulatory submissions for datopotamab deruxtecan in lung cancer and breast cancer are underway in the US and globally.

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