Drugmaker Daiichi Sankyo has risen the most in five months after its novel breast cancer treatment won U.S. approval, a milestone in the company’s efforts to turn it into a widely used blockbuster.
The stock climbed as much as 8% in early morning trading in Tokyo on Monday, the largest intraday gain since Aug. 6.
The U.S. Food and Drug Administration approved the drug, developed with partner AstraZeneca for patients with advanced breast tumors whose cells bear a certain genetic signature. The medicine, called Datroway, parts a tumor-killing drug with an antibody designed to target cancerous tissue — the same technology behind another new cancer treatment co-developed by the companies, Enhertu.
The approval is "a substantial positive” given that the market perceived risk around approval, according to Hidemaru Yamaguchi, an equities analyst at Citigroup Global Markets Japan.
The approval is the first in the United States for Datroway, which got clearance in Japan last month. AstraZeneca and Daiichi Sankyo 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, AstraZeneca and Daiichi Sankyo 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 AstraZeneca 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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