AstraZeneca (AZN) and Daiichi Sankyo's Enhertu, in combination with pertuzumab, was recommended for approval in the European Union as a first-line treatment for adult patients with unresectable or metastatic HER2-positive breast cancer, according to a Friday statement.
The European Medicines Agency's Committee for Medicinal Products for Human Use recommended the approval based on the results of a phase 3 trial, in which the combination therapy reduced the risk of disease progression or death by 44% versus taxane, trastuzumab and pertuzumab (THP) treatment, Daiichi Sankyo said.
The European Commission will now review the recommendation, the company added.