publication date: Nov. 7, 2014

Cyramza Combination Approved In Advanced Stomach Cancer

 

FDA approved Cyramza (ramucirumab) in combination with paclitaxel as a treatment for advanced or metastatic stomach or gastroesophageal junction adenocarcinoma whose cancer has progressed on or after prior fluoropyrimidine- or platinum-containing chemotherapy.

Cyramza now has two FDA approvals for these patients, following an approval in April of Cyramza as a single agent, and was previously granted an Orphan Drug Designation. The latest approval was based on the phase III RAINBOW trial, which compared Cyramza plus paclitaxel to placebo plus paclitaxel. Efficacy endpoints in the trial included overall survival, progression-free survival and objective response rate.

Cyramza is an anti-angiogenic therapy. It is a vascular endothelial growth factor receptor 2 antagonist that blocks the binding of VEGF receptor ligands VEGF-A, VEGF-C, and VEGF-D. Cyramza inhibited angiogenesis in an in vivo animal model.

RAINBOW was a multinational clinical trial initiated in 2010, which randomized 665 patients. Cyramza plus paclitaxel significantly extended median overall survival compared with placebo plus paclitaxel (9.6 months (95% CI: 8.5, 10.8) compared to 7.4 months (95% CI: 6.3, 8.4), respectively (HR=0.81 [95% CI: 0.68, 0.96]; P=0.017).

 

VELOS recently activated its Investigational Drug System at MD Anderson Cancer Center.

The software supports drug inventory and accountability for all investigational agents used at MD Anderson. The product is the result of a multi-year initiative to create a next-generation commercial product to support Investigational Pharmacy Services.

When the system went live, it included over 100 MD Anderson pharmacists and … Continue reading 40-42 Drugs and Targets

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