The European Medicines Agency (EMA) has validated two marketing authorization applications (MAAs) for Daiichi Sankyo and AstraZeneca’s datopotamab deruxtecan, a treatment for two types of cancer. The two MAAs are for the treatment of adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC), and for the treatment of adults with inoperable or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer. The applications were validated on the basis of data from the pivotal TROPION-Lung01 and TROPION-Breast01 phase three trials presented at the 2023 European Society for Medical Oncology Congress. Additional regulatory submissions for datopotamab deruxtecan in lung cancer and breast cancer are underway in the US and globally.

Source link: http://www.businesswire.com/news/home/20240301286060/en/Two-Datopotamab-Deruxtecan-Applications-Validated-in-the-EU-for-Patients-with-Advanced-Nonsquamous-Non-Small-Cell-Lung-Cancer-or-HR-Positive-HER2-Negative-Breast-Cancer

Jon Napitupulu
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Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.