FDA approves zolbetuximab BLA resubmission for 1L locally advanced unresectable or metastatic CLDN18.2+ve HER2-neg gastric or GEJ adenocarcinoma; new PDUFA: Nov 9, 2024 June 4, 2024
FDA Approval for TEVIMBRA® for the Treatment of Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Prior Chemotherapy March 19, 2024
FDA Approves KEYTRUDA + Chemotherapy as 1L Treatment for Locally Advanced Unresectable or Metastatic HER2-Negative Gastric or GEJ Adenocarcinoma November 29, 2023
Positive EU CHMP Opinion for KEYTRUDA + Chemo as 1L Treatment for HER2-Negative Advanced GEJ Adenocarcinoma Expressing PD-L1 (CPS ≥1) October 16, 2023
European Commission Approves KEYTRUDA + Trastuzumab and Chemo as 1L Treatment for HER2-Positive Advanced GEJ Adenocarcinoma Expressing PD-L1 September 6, 2023
KEYTRUDA + Trastuzumab + Chemo Met Primary Endpoint of PFS as 1L Treatment in Patients With HER2-Positive Advanced GEJ Adenocarcinoma July 27, 2023
FAILED TRIAL: Ph 3 KEYNOTE-585 Trial in GEJ Adenocarcinoma didn’t meet primary endpoint of EFS June 28, 2023
KEYTRUDA + Trastuzumab and Chemotherapy Met Primary Endpoint of PFS as 1L Treatment in Patients With HER2-Positive Advanced GEJ Adenocarcinoma June 21, 2023
NDA submitted to Japan’s MHLW for zolbetuximab in 1L CLDN18.2-positive HER2-neg gastric or gastroesophageal junction (mGEJ) adenocarcinoma patients June 14, 2023
IMFINZI + chemo significantly improved pathologic complete response in gastric and gastroesophageal junction cancers in MATTERHORN Ph 3 trial June 6, 2023
FDA Accepts Application for KEYTRUDA + Chemo as 1L Treatment for Locally Advanced Unresectable or Metastatic Gastric or GEJ Adenocarcinoma April 20, 2023
NMPA grants Tislelizumab + chemo approval for 1L use in advanced gastric or gastroesophageal junction adenocarcinoma with high PD-L1 expression February 28, 2023
KEYTRUDA + Chemo Significantly Improved OS vs chemo Alone in With HER2-Neg Gastric or GEJ Adenocarcinoma Patients Regardless of PD-L1 Expression February 22, 2023
ASCO GI: 84% Overall Survival at 18 Months from Ph 2 Trial Evaluating Zanidatamab in HER2-Expressing Metastatic Gastroesophageal Adenocarcinoma announced February 1, 2023
Jazz Pharmaceuticals and Zymeworks Announce Jazz has Confirmed Opt-in and Advances Partnership for Zanidatamab January 4, 2023
Zolbetuximab Meets Primary Endpoint in Ph 3 GLOW Trial as 1L Treatment in Claudin 18.2 +ve HER2-neg Locally Advanced Unresectable or Metastatic GEJ Cancers December 19, 2022
Ph 3 KEYNOTE-859 Trial Met Primary Endpoint of Overall Survival in Patients With HER2-Negative Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma November 30, 2022
First Patient Enrolled in Part C of Ph 2 DisTinGuish Study of DKN-01 in Combination with Tislelizumab for the Treatment of Gastric or Gastroesophageal Junction Cancer October 19, 2022
