Astrazeneca (AZN) said Friday its Enhertu drug has been recommended for approval in the European Union for treatment of adults with HER2 low or HER2 ultralow metastatic breast cancer following at least one endocrine therapy.
Enhertu is a antibody drug conjugate discovered by Daiichi Sankyo and being jointly developed and commercialized by the two companies.
The Committee for Medicinal Products for Human Use of the European Medicines Agency, which gave the recommendation for approval, based its opinion on results from a phase 3 trial that evaluated the efficacy and safety of the drug, Astrazeneca said.
The recommendation will be reviewed by the European Commission, which has the authority to grant marketing authorization for the drug, the company said.