Biopharmaceutical company AstraZeneca plc (STO:AZN) (LON:AZN) (Nasdaq:AZN) and Japanese healthcare company Daiichi Sankyo Co Ltd (TYO:4568) announced on Friday that the Committee for Medicinal Products for Human Use (CHMP) has recommended approval in the European Union for datopotamab deruxtecan for patients with previously treated metastatic hormone receptor (HR) positive, HER2 negative breast cancer.

Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by Daiichi Sankyo and AstraZeneca.

The recommendation is based on the TROPION-Breast01 phase 3 trial, which showed that datopotamab deruxtecan reduced the risk of disease progression or death by 37% compared to chemotherapy. Patients treated with the drug had a median progression-free survival of 6.9 months versus 4.9 months with chemotherapy. The objective response rate was 36% for datopotamab deruxtecan compared to 23% for chemotherapy.

Datopotamab deruxtecan demonstrated a favourable safety profile with no new safety concerns.

The European Commission will now review the CHMP opinion before making a final decision on approval.

The drug is already approved in the United States and Japan for the same patient population. Regulatory reviews are ongoing in China and other regions.