This marks a significant step in the potential approval of the medication for use in the European Union.
One application pertains to the treatment of adults with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who are in need of systemic therapy after previous treatment.
The other MAA sought approval for treating adults with hormone receptor (HR) positive, HER2 (IHC 0, IHC 1+ or IHC 2+/ISH-) negative breast cancer that is either unresectable or metastatic, in patients who are not eligible to receive endocrine therapy and have received a minimum of one systemic therapy.
A targeted TROP2 directed DXd antibody drug conjugate (ADC), datopotamab deruxtecan is discovered by Daiichi Sankyo and is being co-developed with AstraZeneca.
The validation of the MAAs by the EMA confirms the completion of the submission process and triggers the start of the scientific review by the EMA’s Committee for Medicinal Products for Human Use.
The data underpinning these applications come from the TROPION-Lung01 and TROPION-Breast01 Phase III clinical trials.
These international, multicentre, randomised, open-label trials evaluated the efficacy and safety of datopotamab deruxtecan compared to other treatments in patients with NSCLC and HR positive, HER2 negative breast cancer.
Daiichi Sankyo R&D global head Ken Takeshita said: “The EMA validation is an important first step toward bringing this TROP2 directed antibody drug conjugate to eligible patients in Europe with nonsquamous lung cancer and HR positive, HER2 negative breast cancer.
“This news builds on our recent regulatory progress in the US, where our lung cancer application has been accepted and our breast cancer application is underway, underscoring our commitment to changing the standard of care by developing new medicines to help as many patients worldwide as possible.”