AstraZeneca and Daiichi Sankyo’s Datroway breast cancer treatment, which the companies expect will eventually become a blockbuster, was recommended for approval in the European Union.
The green light from the European Medicines Agency is the first backing in the EU for the medicine, following its approval in the U.S. and Japan.
Datroway is used to treat patients with a type of breast cancer that has spread or can’t be removed by surgery, and whose cells bear a certain genetic signature. The treatment pairs a tumor-killing drug with an antibody designed to home in on cancerous tissue.
In December, Astra and Daiichi withdrew an application in the EU for the drug to treat a type of lung cancer after feedback from regulatory advisers. Mixed results from a late-stage trial showed that, while some patients benefited from the drug, results across all patients weren’t statistically significant. An earlier trial in a type of breast cancer also showed disappointing results.
Still, Astra and Daiichi are optimistic about the use of Datroway to treat some patients with breast and lung cancers. The drug, previously called Dato-DXd, is among a group that Astra is counting on for peak annual sales of at least $5 billion, to help it reach $80 billion in annual revenue by the end of the decade.
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