EMA Validates Parallel Applications for Datopotamab Deruxtecan in Two Types of Cancer

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EMA has validated two MAAs submitted by AstraZeneca and Daiichi Sankyo for datopotamab deruxtecan in two types of cancer.

The European Medicines Agency (EMA) announced on March 4, 2024 that it has validated two marketing authorization applications (MAAs) submitted by AstraZeneca and Daiichi Sankyo for their antibody drug conjugate (ADC) candidate, datopotamab deruxtecan (Dato-DXd). The parallel applications are seeking indications in two types of cancer: locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) and unresectable or metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer in patients who have progressed on and are not suitable for endocrine therapy and who have received at least one additional systemic therapy.

The agency’s validations confirm that the MAAs are complete, and the agency can now commence the scientific review process, which is to be carried out by EMA’s Committee for Medicinal Products for Human Use. The two applications are based on data from two pivotal Phase III clinical trials (TROPION-Lung01 and TROPION-Breast01), which were presented during two Presidential Symposia at the 2023 European Society for Medical Oncology Congress.

Datopotamab deruxtecan is an ADC specifically engineered to target TROP2, a protein broadly expressed in several solid tumors, including the majority of NSCLC and HR-positive, HER2-negative breast cancer cases. High TROP2 expression is associated with increased progression of tumors and poor survival. Currently, there is no approved TROP2-directed ADC for treating lung cancer, according to an AstraZeneca press release.

Datopotamab deruxtecan was discovered by Daiichi Sankyo and is being jointly developed by AstraZeneca and Daiichi Sankyo. The companies entered into a global collaboration for the ADC in July 2020 (1). AstraZeneca has rights to the product except in Japan, where Daiichi Sankyo maintains exclusive rights. Meanwhile, Daiichi Sankyo is responsible for the manufacturing and supply of the ADC.

“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,” said Susan Galbraith, executive vice-president, Oncology R&D, AstraZeneca, in the press release.

“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 [United States], 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," said Ken Takeshita, global head, R&D, Daiichi Sankyo, in the press release.


Regulatory submissions for the ADC in lung cancer and breast cancer are also underway in the US and globally.


1. AstraZeneca. AstraZeneca and Daiichi Sankyo Enter Collaboration to Develop and Commercialize New Antibody Drug Conjugate. Press Release, July 27, 2020.

Source: AstraZeneca