AstraZeneca and Daiichi Sankyo won U.S. approval for a novel breast cancer treatment, a milestone in the companies’ efforts to turn the medicine into a widely used blockbuster.
The Food and Drug Administration approved the drug for patients with advanced breast tumors whose cells bear a certain genetic signature. The treatment, called Datroway, pairs a tumor-killing drug with an antibody designed to home in on cancerous tissue — the same technology behind another new cancer medicine co-developed by the companies, Enhertu.
The approval is the first in the U.S. for Datroway, which got clearance in Japan last month. Astra and Daiichi withdrew an application in the European Union for the drug to treat a type of lung cancer in December following feedback from regulatory advisers.
Mixed results from a late-stage trial last year showed that while some lung cancer patients benefited from the drug, results across all patients weren’t statistically significant. Another 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, also called Dato-DXd, is among a group that Astra is counting on for peak annual sales of at least $5 billion to help reach $80 billion in annual revenue by the end of the decade.
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