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Gastroesophageal Junction Cancer

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October 28, 2020
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FDA grants priority review to Enhertu for gastric cancer subset

The FDA granted priority review to fam-trastuzumab deruxtecan-nxki for treatment of HER2-positive metastatic gastric cancer or gastroesophageal junction adenocarcinoma.

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October 19, 2020
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FDA grants orphan drug designation to APX005M for three cancer types

The FDA granted orphan drug designation to APX005M for the treatment of three gastrointestinal cancer types, according to the agent’s manufacturer.

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October 07, 2020
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FDA grants orphan drug designation to CAR T-cell therapy for advanced gastric cancers

The FDA granted orphan drug designation to CT041 for the treatment of adults with relapsed or refractory gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, according to the agent’s manufacturer.

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September 29, 2020
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Nivolumab may be ‘new standard’ in esophageal, gastroesophageal junction cancers

Adjuvant nivolumab significantly prolonged DFS compared with placebo among patients with resected esophageal and gastroesophageal junction cancer, according to results of the CheckMate 577 trial presented during ESMO Virtual Congress 2020.

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September 25, 2020
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Nivolumab plus chemotherapy prolongs PFS in gastric, gastroesophageal junction cancer

The addition of nivolumab to first-line chemotherapy significantly improved PFS, but not OS, for patients with advanced or recurrent HER2-negative gastric and gastroesophageal junction cancer, according to phase 3 study findings.

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September 24, 2020
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FDA grants fast track designation to DKN-01 for two gastrointestinal cancers

The FDA granted fast track designation to DKN-01 for the treatment of certain patients with gastric cancer or gastroesophageal junction adenocarcinoma, according to the agent’s manufacturer.

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September 21, 2020
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Nivolumab regimen superior to chemotherapy alone in advanced gastric, esophageal cancers

Nivolumab plus chemotherapy increased PFS and OS compared with chemotherapy alone among previously untreated patients with advanced gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma, study results showed.

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June 15, 2020
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FDA grants orphan drug status to DKN-01 for certain gastrointestinal cancers

The FDA granted orphan drug designation to DKN-01 for the treatment of gastric or gastroesophageal junction cancers.

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May 11, 2020
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FDA grants fast track status to several agents

The FDA granted fast track designation to several therapies in development for hematology or oncology indications.

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May 11, 2020
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FDA grants breakthrough therapy designation to Enhertu for gastric cancer subset

The FDA granted breakthrough therapy designation to fam-trastuzumab deruxtecan-nxki for treatment of patients with HER2-positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

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