Gastroesophageal Junction Adenocarcinoma

• FDA approval · 2026-04-15
  FDA Approved: ONTRUZANT — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for ONTRUZANT (trastuzumab) submitted by Organon LLC. The approval encompasses labeling updates rela…

• FDA approval · 2025-06-06
  FDA Approved: VYLOY — Supplemental Application (Astellas Pharma US, Inc.)

  FDA approved a supplemental application for VYLOY (zolbetuximab) from Astellas Pharma US, expanding/updating its labeling.

• FDA approval · 2025-01-27
  FDA Approved: CYRAMZA — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for CYRAMZA (ramucirumab) from Eli Lilly and Company.

• CLINICAL_TRIALS approval · 2025-01-09
  Clinical Trial Update: Ramucirumab Use in Combination With Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma; Temporary Authorization for Use (ATU) in France

  France granted a temporary authorization for use (ATU) of ramucirumab in combination with paclitaxel for gastric or gastroesophageal junctio…

• FDA approval · 2024-11-13
  FDA Approved: OGIVRI — Supplemental Application (Biocon Biologics Inc.)

  The FDA approved a supplemental application for OGIVRI (trastuzumab-dkst) from Biocon Biologics Inc.

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• FDA approval · 2024-10-18
  FDA Approved: VYLOY — Original Application (Astellas Pharma US, Inc.)

  FDA approved the original Biologics License Application for VYLOY (zolbetuximab) from Astellas Pharma US, enabling its use for a gastric/gas…

• FDA approval · 2022-08-11
  FDA Approved: ENHERTU — Supplemental Application (Daiichi Sankyo Inc.)

  FDA approved a supplemental application for ENHERTU (fam-trastuzumab deruxtecan-nxki) filed by Daiichi Sankyo, Inc.

• FDA approval · 2019-06-28
  FDA Approved: OGIVRI — Supplemental Application (Biocon Biologics Inc.)

  FDA approved a supplemental Biologics License Application for OGIVRI (trastuzumab-dkst) from Biocon Biologics Inc., updating its labeling/pe…

• FDA approval · 2014-04-21
  FDA Approved: CYRAMZA — Original Application (Eli Lilly and Company)

  The FDA approved the original application for ramucirumab (CYRAMZA) by Eli Lilly for metastatic gastric or gastroesophageal junction adenoca…