Phase II registrational trial of Enhertu to treat HER2-positive unresectable or metastatic gastric or gastroesophageal junction cancer . AstraZeneca + Daiichi Sankyo
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AstraZeneca and Daiichi Sankyo have announced that the FDA has approved label expansion for Enhertu (fam-trastuzumab deruxtecan-nxki) to include adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma that would have previously been treated with a trastuzumab-based regimen.
Enhertu (trastuzumab deruxtecan) from AstraZeneca and Daiichi Sankyo Company, Limited, has received acceptance for its supplemental Biologics License Application (sBLA) and has also been granted Priority Review in the US for the treatment of patients with HER2-positive metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Bristol Myers Squibb announced that CheckMate -649, a pivotal Phase III trial evaluating Opdivo (nivolumab) plus chemotherapy compared to chemotherapy alone as a first-line treatment for metastatic gastric cancer, gastroesophageal junction (GEJ) cancer or esophageal adenocarcinoma