Daiichi Sankyo (4568 JP) has received FDA approval for Datroway for the second-line treatment of unresectable or metastatic hormone receptor (HR) positive, HER2 negative breast cancer.
Last month, Datroway got approval in Japan. Regulatory submissions for the drug are under review in the EU, China, and other regions. The drug is undergoing trial for other indications.
AstraZeneca’s proven commercialization capability for Enhertu enhances conviction on the commercialization prospect of Datroway too. AstraZeneca pegged peak year revenue of Datroway at more than $5B (similar level to Enhertu).
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