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.
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.