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

FDA approves Vyloy+chemo for gastric or GEJ junction adenocarcinoma with CLDN18.2-positive tumors

FDA has approved Vyloy (zolbetuximab-clzb), a claudin 18.2-directed cytolytic antibody, with fluoropyrimidine- and platinum-containing chemotherapy, 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, as determined by an FDA-approved test.

October 25, 2024

Vol.50 No.40

Regulatory News

ODAC votes decisively in support of PD-L1 expression as predictive biomarker for checkpoint inhibitors
Vote may lead to rollback of some indications held by BMS and Merck

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

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.

EC approves Vyloy + chemo for advanced gastric and GEJ cancers

The European Commission approved Vyloy (zolbetuximab) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin 18.2 positive.

September 27, 2024

Vol.50 No.36

Clinical Trials & Tribulations

Is gastrectomy indicated?
A study recently published in JAMA suggests lower lifetime gastric cancer risk for CDH1 mutation carriers. Will this lead to changes in management recommendations?

A study recently published in JAMA sheds light on cancer risks associated with carrying germline CDH1 mutations, challenging previous, potentially inflated, lifetime cancer risk estimates.

September 06, 2024

Vol.50 No.33

By Rebecca Sutphen, Sue Friedman and Jon Florin

Clinical Roundup

Esopredict test helps ID patients at high risk of esophageal cancers

Esopredict, a test developed by Johns Hopkins Kimmel Cancer Center investigators, could give gastroenterologists insight into which patients with Barrett’s esophagus are likely to progress to esophageal cancer or an abnormal collection of cells called high-grade dysplasia, according to a recent study. This information could help physicians determine how to monitor or manage patients during clinical care.

September 06, 2024

Vol.50 No.33

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

YOU MAY BE INTERESTED IN

FDA approves Vyloy+chemo for gastric or GEJ junction adenocarcinoma with CLDN18.2-positive tumors

ODAC votes decisively in support of PD-L1 expression as predictive biomarker for checkpoint inhibitors
Vote may lead to rollback of some indications held by BMS and Merck

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

EC approves Vyloy + chemo for advanced gastric and GEJ cancers

Is gastrectomy indicated?
A study recently published in JAMA suggests lower lifetime gastric cancer risk for CDH1 mutation carriers. Will this lead to changes in management recommendations?

Esopredict test helps ID patients at high risk of esophageal cancers

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

YOU MAY BE INTERESTED IN

FDA approves Vyloy+chemo for gastric or GEJ junction adenocarcinoma with CLDN18.2-positive tumors

ODAC votes decisively in support of PD-L1 expression as predictive biomarker for checkpoint inhibitorsVote may lead to rollback of some indications held by BMS and Merck

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

EC approves Vyloy + chemo for advanced gastric and GEJ cancers

Is gastrectomy indicated?A study recently published in JAMA suggests lower lifetime gastric cancer risk for CDH1 mutation carriers. Will this lead to changes in management recommendations?

Esopredict test helps ID patients at high risk of esophageal cancers

Login

ODAC votes decisively in support of PD-L1 expression as predictive biomarker for checkpoint inhibitors
Vote may lead to rollback of some indications held by BMS and Merck

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

Is gastrectomy indicated?
A study recently published in JAMA suggests lower lifetime gastric cancer risk for CDH1 mutation carriers. Will this lead to changes in management recommendations?