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The Phase III trial will compare Enhertu against Kadcyla as an adjuvant treatment for early-stage HER2-positive breast cancer patients.
The FDA also granted priority review for Enhertu for the treatment of patients with HER2-positive metastatic gastric cancer.
Enhertu, or trastuzumab deruxtecan, will also receive accelerated assessment by the European Medicines Agency's Committee for Medicinal Products for Human Use.
