AstraZeneca Plc. and Daiichi Sankyo have announced that the European Medicines Agency (EMA) has approved two marketing applications for their cancer drug, datopotamab deruxtecan or Dato-DXd, in two distinct cancer types.
The first application targets the treatment of adults suffering from locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC), who require systematic therapy following prior treatment.
The second application is dedicated to treating adults suffering from unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer. This treatment is applicable for those who have progressed and are not suitable for endocrine therapy, and have already received at least one additional systemic therapy.
These validations indicate the completion of the applications and begin the scientific review process by the EMA’s Committee for Medicinal Products for Human Use.
Datopotamab deruxtecan, which is a TROP2-directed DXd antibody drug conjugate (ADC) specifically engineered, was discovered by Daiichi Sankyo and is being developed collaboratively by AstraZeneca and Daiichi Sankyo.
AstraZeneca and Daiichi Sankyo have also noted that further regulatory submissions for datopotamab deruxtecan for lung and breast cancer are currently in progress both in the US and globally.
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