AstraZeneca (AZN) and Daiichi Sankyo's datopotamab deruxtecan has been recommended for approval in the EU to treat people with breast cancer, the companies said Friday.
The positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency was based on results from a phase 3 trial, the companies said, adding the recommendation will now be reviewed by the European Commission.
The phase 3 trial showed the drug decreased the risk of disease progression or death by 37% compared with chemotherapy, the companies said. The drug is approved in the US and Japan for the same patient population, they said.
Datopotamab deruxtecan, which was discovered by Daiichi Sankyo, is being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca, the companies said.
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