Pharmaceutical company Daiichi Sankyo Company Limited announced on Monday that it has received the European Medicines Agency's (EMA) validation for the Marketing Authorization Application (MAA) for trastuzumab deruxtecan for the treatment of adults with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2 based regimens.

The company added the trastuzumab deruxtecan, a HER2 directed antibody drug conjugate (ADC), passed accelerated assessment by the EMA's Committee for Medicinal Products for Human Use (CHMP). HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including gastric, breast and lung cancers. About one in five breast cancers are HER2 positive.

Utilizing the company's proprietary DXd ADC technology, trastuzumab deruxtecan is comprised of a HER2 monoclonal antibody attached to a novel topoisomerase I inhibitor payload by a tetrapeptide-based linker. ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells.

This MAA is based on the positive results from the company's pivotal phase 2 DESTINY-Breast01 trial of trastuzumab deruxtecan monotherapy in patients with HER2 positive metastatic breast cancer who had received two or more prior anti-HER2 regimens. The results of the DESTINY-Breast01 trial are published in The New England Journal of Medicine.