LONDON (dpa-AFX) - Daiichi Sankyo Company Limited (DSKYF) and AstraZeneca's (AZN) supplemental Biologics License Application (sBLA) for Datroway has been granted Priority Review by the U.S. Food and Drug Administration (FDA) for the treatment of adults with metastatic triple-negative breast cancer (TNBC) who are not candidates for immunotherapy, Daiichi Sankyo said Tuesday.
The Prescription Drug User Fee Act (PDUFA) action date for the regulatory decision is set for June 2, 2026.
Datroway is an antibody-drug conjugate (ADC) discovered by Daiichi Sankyo and co-developed and commercialized with AstraZeneca.
The sBLA is based on results from the Phase 3 TROPION-Breast02 trial, which showed a statistically significant 5-month improvement in median overall survival and a 43% reduction in the risk of disease progression or death.
Additional regulatory submissions for Datroway in breast and lung cancer are underway globally.
Datroway is already approved in more than 40 countries and regions for unresectable or metastatic HR-positive, HER2-negative breast cancer, and in Russia and the U.S. for EGFR-mutated non-small cell lung cancer (NSCLC).
The drug is currently being evaluated in more than 20 clinical trials across multiple cancers, including NSCLC, TNBC, and urothelial cancer.
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