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Home » AstraZeneca and Daiichi Sankyo Win FDA Nod for Enhertu Treating HER2-Positive Gastric Cancer
AstraZeneca and Daiichi Sankyo Win FDA Nod for Enhertu Treating HER2-Positive Gastric Cancer
AstraZeneca’s and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved by the FDA for treating adult patients with HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.
The agency approved the antibody drug conjugate for treating adults with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma who have received a prior trastuzumab-based regimen.
The approval was based on positive results from a phase 2 trial in Japan and South Korea that showed Enhertu led to improvement in overall survival and response rate vs. chemotherapy.
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