Daiichi Sankyo Company Limited, DSKYF, 4568.T, FDA Calendar, PDUFA Date

Company Name	Daiichi Sankyo Company Limited DSKYF, 4568.T
Drug Name	DATROWAY (sBLA)
Event Name	FDA decision on DATROWAY for the treatment of adult patients with unresectable or metastatic triple negative breast cancer who are not candidates for immunotherapy
Event Date	06/02/2026
Outcome Date
Outcome	Pending
Drug Status	Daiichi Sankyo and AstraZeneca have a global collaboration to jointly develop and commercialize DATROWAY, except in Japan where Daiichi Sankyo maintains exclusive rights for it
Rival Drugs
Market Potential
Other Approvals	DATROWAY is already approved for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer, and epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer.
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