Imfinzi + chemo more than doubled pathologic CRR in gastric, gastroesophageal junction cancers

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

Clinical Roundup

Imfinzi + chemo shows improved EFS and OS in muscle-invasive bladder cancer

Positive results from the NIAGARA phase III trial showed Imfinzi (durvalumab)in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of event-free survival and the key secondary endpoint of overall survival versus neoadjuvant chemotherapy for patients with muscle-invasive bladder cancer.

September 20, 2024

Vol.50 No.35

Imfinzi + chemo more than doubled pathologic CRR in gastric, gastroesophageal junction cancers

YOU MAY BE INTERESTED IN

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

Imfinzi + chemo shows improved EFS and OS in muscle-invasive bladder cancer

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Imfinzi + chemo more than doubled pathologic CRR in gastric, gastroesophageal junction cancers

YOU MAY BE INTERESTED IN

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

Imfinzi + chemo shows improved EFS and OS in muscle-invasive bladder cancer

Never miss an issue!

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