EMA validates two applications for datopotamab deruxtecan for cancer treatments
Betsy Goodfellow | March 4, 2024 | News story | Medical Communications | CHMP, Daiichi Sankyo, EMA, Oncology, datopotamab deruxtecan
AstraZeneca has announced that the European Medicines Agency (EMA) has validated to marketing authorisation applications (MAAs) for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan (Dato-DXd) in the treatment of two cancers.
The first MAA is for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who require systemic therapy following previous treatments.
The second MAA covers the treatment of adult patients with unresectable of metastatic hormone receptor (HR)-positive, HER2-negatice (IHC 0, IHC 1+ or IHC2+/ISH-) breast cancer who have progressed on or are not suitable for endocrine therapy and have had at least one previous systemic therapy.
These MAAs are based on data from the phase 3 TROPION-Lung01 and TROPION-Breast01 trials and commence the scientific review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP).
Susan Galbraith, executive vice president of Oncology research and development at AstraZeneca, commented: “Our ambition is for datopotamab deruxtecan to improve upon and replace conventional chemotherapy in the treatment of multiple cancer types. Today’s dual validation of our applications in lung and breast cancers brings this potential medicine a meaningful step closer to redefining treatment expectations for patients with two of the most common cancers in Europe.”
Betsy Goodfellow
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