First Pharmaceutical (DSNKY.US) and AstraZeneca (AZN.US) have received a recommendation for the potential approval of their blockbuster cancer treatment ADC in the EU.

First-US (DSNKY.US) announced that its antibody-drug conjugate (ADC) datopotamab deruxtecan (Dato-DXd) developed in collaboration with AstraZeneca (AZN.US) has been recommended for marketing authorization by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP), for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative (IHC0, IHC1+ or IHC2+/ISH-) breast cancer who have received endocrine therapy and at least one line of chemotherapy for advanced disease. The recommendation will be submitted to the European Commission (EC), which will decide on the final approval of the drug.

It is known that Datopotamab deruxtecan is an ADC generated by the conjugation of a humanized, trop2-targeting monoclonal antibody with the innovative DNA topoisomerase I inhibitor (DXd) through a cleavable tetrapeptide linker. DXd has a unique mechanism of action, with 10 times the activity of the commonly used chemotherapy drug irinotecan. Moreover, the drug has strong membrane penetration ability, allowing it to kill nearby cancer cells after killing the cancer cells that have ingested the ADC, producing a "bystander effect". AstraZeneca and First-US reached an agreement in July 2020 to collaborate on the development of this ADC.

According to public information, Dato-DXd was granted global first approval in Japan in December 2024 for the treatment of adult patients with hormone receptor-positive, HER2-negative, unresectable or recurrent breast cancer who have received chemotherapy; the US FDA approved the therapy for the same patient population in January 2025.