Japanese healthcare company Daiichi Sankyo Co Ltd (TYO:4568) announced on Friday that Enhertu (trastuzumab deruxtecan) has been recommended for approval in the European Union as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumours who have previously received treatment and have no satisfactory treatment options.

Enhertu is an HER2-directed antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised with British-Swedish biopharmaceutical company AstraZeneca plc (STO:AZN) (LON:AZN) (NYSE:AZN).

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on data from three phase 2 studies: DESTINY-PanTumor02, DESTINY-Lung01, and DESTINY-CRC02.

In DESTINY-PanTumor02, Enhertu achieved a confirmed objective response rate of 51.4% and a median duration of response of 14.2 months across multiple tumours including biliary tract, bladder, cervical, endometrial, ovarian, and pancreatic tumours. In DESTINY-Lung01, it demonstrated a 52.9% objective response rate with a median duration of response of 6.9 months in non-small cell lung cancer (NSCLC). In DESTINY-CRC02, the therapy showed a 46.9% objective response rate and a median duration of response of 5.5 months in colorectal cancer.

Across the studies, the safety profile at 5.4 mg/kg was consistent with prior trials, with no new safety concerns identified.

The recommendation will now be reviewed by the European Commission for potential marketing authorisation.