DATROWAY (AstraZeneca Pty Ltd)
Product name
DATROWAY
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
179 (255 working days)
Active ingredients
datopotamab deruxtecan
Registration type
NCE/ NBE
Indication
DATROWAY as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine therapy and at least one additional systemic therapy in the locally advanced or metastatic setting.