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FDA Approves Ramucirumab Plus Paclitaxel for Advanced Gastric Cancer
The drug combination showed a significant improvement of 2.2 months in OS compared to the placebo arm.
On November 5, 2014, the FDA approved ramucirumab (Cyramza, Eli Lilly and Company) for use in combination with paclitaxel for the treatment of patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. Ramucirumab was approved in April, 2014 as a single agent for the treatment of patients with advanced gastric or GEJ adenocarcinoma refractory to or progressive following first-line therapy with platinum or fluoropyrimidine chemotherapy.
The approval of ramucirumab in combination with paclitaxel was based on the demonstration of improved overall survival in a multicenter, double-blind, placebo-controlled study (I4T-IE-JVBE) that enrolled 665 patients with previously-treated advanced or metastatic gastric or GEJ adenocarcinoma. Patients were randomized to receive either ramucirumab (8 mg/kg every 2 weeks) in combination with paclitaxel (80 mg/m2 once a week for 3 weeks of every 28-day cycle) (n = 330) or matching placebo plus paclitaxel (n = 335).
Link to the report on the FDA website: http://1.usa.gov/1uAHO1p
Oncology Onward: A Conversation With Penn Medicine's Dr Justin Bekelman
December 19th 2023Justin Bekelman, MD, director of the Penn Center for Cancer Care Innovation, sat with our hosts Emeline Aviki, MD, MBA, and Stephen Schleicher, MD, MBA, for our final episode of 2023 to discuss the importance of collaboration between academic medicine and community oncology and testing innovative cancer care delivery in these settings.
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