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

FDA approves Tevimbra + chemo for first-line treatment of gastric and GEJ cancers

FDA approved Tevimbra (tislelizumab-jsgr) in combination with platinum and fluoropyrimidine-based chemotherapy for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma in adults whose tumors express PD-L1 (≥1).

January 10, 2025

Vol.51 No.01

Drugs & Targets

LINDIS Biotech signs licensing agreement with Pharmanovia for the commercialization of catumaxomab

Lindis Biotech GmbH announced a licensing agreement with global pharmaceutical company Pharmanovia for catumaxomab, for the treatment of malignant ascites.

November 22, 2024

Vol.50 No.44

Drugs & Targets

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

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

YOU MAY BE INTERESTED IN

FDA approves Tevimbra + chemo for first-line treatment of gastric and GEJ cancers

LINDIS Biotech signs licensing agreement with Pharmanovia for the commercialization of catumaxomab

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

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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 Tevimbra + chemo for first-line treatment of gastric and GEJ cancers

LINDIS Biotech signs licensing agreement with Pharmanovia for the commercialization of catumaxomab

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

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