UK pharma major AstraZeneca (LSE: AZN) on Friday revealed that Datroway (datopotamab deruxtecan or Dato-DXd) has been approved in the USA.
The approval by the US Food and Drug Administration (FDA) is 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 prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease. The approval was based on results from the TRPION-Brease01 Phase III trial.
The list price of Datroway is $4,891.07 per vial, AstraZeneca said. It will be available to patients in the USA by prescription in about two weeks.
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