Johns Hopkins researchers generate lab-grown human tissue model for gastroesophageal junction cancer

ODAC votes overwhelmingly in support of PD-L1 expression as predictive biomarker for efficacy of checkpoint inhibitors
Vote applies across drugs and indications

The FDA Oncologic Drugs Advisory Committee on Sept. 26 voted that PD-L1 inhibitors should not be indicated for patients with PD-L1-negative gastric/gastroesophageal junction adenocarcinoma and esophageal squamous cell carcinoma.

FDA acknowledges BLA resubmission for Zolbetuximab for HER2- gastric or GEJ adenocarcinoma with CLDN18.2-positive tumors

Astellas Pharma Inc. announced that FDA has acknowledged the company’s resubmission of the Biologics License Application for zolbetuximab, a first-in-class investigational claudin 18.2-targeted monoclonal antibody, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are CLDN18.2 positive.

May 31, 2024

Vol.50 No.22

Drugs & Targets

FDA accepts BLA for Tevimbra for 1L treatment of G/GEJ cancers

FDA has accepted a Biologics License Application for Tevimbra (tislelizumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

March 01, 2024

Vol.50 No.09

Drugs & Targets

FDA approves Keytruda + chemo for HER2-negative gastric or GEJ cancer

FDA approved Keytruda (pembrolizumab) with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.

November 17, 2023

Vol.49 No.43

Clinical Roundup

Preliminary data from phase II EDGE-Gastric study demonstrate promising ORR and six-month PFS results

Preliminary data from Arm A1 of the phase II EDGE-Gastric study showed promising overall response rate and six-month progression-free-survival results, irrespective of PD-L1 expression.

November 10, 2023

Vol.49 No.42

Drugs & Targets

CHMP issues positive opinion for Keytruda + chemo as first-line treatment for HER2-negative, PD-L1-positive advanced gastric or GEJ cancer

The European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of Keytruda (pembrolizumab) in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma in adults whose tumors express PD-L1.

October 20, 2023

Vol.49 No.39

Johns Hopkins researchers generate lab-grown human tissue model for gastroesophageal junction cancer

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ODAC votes overwhelmingly in support of PD-L1 expression as predictive biomarker for efficacy of checkpoint inhibitors
Vote applies across drugs and indications

FDA acknowledges BLA resubmission for Zolbetuximab for HER2- gastric or GEJ adenocarcinoma with CLDN18.2-positive tumors

FDA accepts BLA for Tevimbra for 1L treatment of G/GEJ cancers

FDA approves Keytruda + chemo for HER2-negative gastric or GEJ cancer

Preliminary data from phase II EDGE-Gastric study demonstrate promising ORR and six-month PFS results

CHMP issues positive opinion for Keytruda + chemo as first-line treatment for HER2-negative, PD-L1-positive advanced gastric or GEJ cancer

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Johns Hopkins researchers generate lab-grown human tissue model for gastroesophageal junction cancer

YOU MAY BE INTERESTED IN

ODAC votes overwhelmingly in support of PD-L1 expression as predictive biomarker for efficacy of checkpoint inhibitorsVote applies across drugs and indications

FDA acknowledges BLA resubmission for Zolbetuximab for HER2- gastric or GEJ adenocarcinoma with CLDN18.2-positive tumors

FDA accepts BLA for Tevimbra for 1L treatment of G/GEJ cancers

FDA approves Keytruda + chemo for HER2-negative gastric or GEJ cancer

Preliminary data from phase II EDGE-Gastric study demonstrate promising ORR and six-month PFS results

CHMP issues positive opinion for Keytruda + chemo as first-line treatment for HER2-negative, PD-L1-positive advanced gastric or GEJ cancer

Never miss an issue!

Login

ODAC votes overwhelmingly in support of PD-L1 expression as predictive biomarker for efficacy of checkpoint inhibitors
Vote applies across drugs and indications