EMA validates two MAAs for Daiichi Sankyo, AstraZeneca datopotamab deruxtecan

The European Medicines Agency, or EMA, has validated two marketing authorization applications, or MAAs, for Daiichi Sankyo and AstraZeneca’s datopotamab deruxtecan in two types of cancer. One MAA is for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer, or NSCLC, who require systemic therapy following prior treatment. The other MAA is for the treatment of adult patients with unresectable or metastatic hormone receptor positive, HER2 negative breast cancer who have progressed on and are not suitable for endocrine therapy and received at least one additional systemic therapy.