On April 21, 2014, the FDA approved ramucirumab (Cyramza; Eli Lilly) for the treatment of patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma. Ramucirumab is an angiogenesis inhibitor that is intended to be used in patients with unresectable cancer or with metastatic stomach cancer after receiving chemotherapy with a fluoropyrimidine- or a platinum-containing agent. This is the first FDA-approved therapy for patients with stomach cancer who have received chemotherapy.
Ramucirumab was approved under the FDA’s priority review program, and was also granted an orphan drug status, because it is intended to treat rare conditions.
The safety and efficacy of ramucirumab were demonstrated in a clinical trial of 355 patients with unresectable or metastatic stomach or gastroesophageal junction cancer. Patients were randomized to ramucirumab (66%) or to placebo (34%). The main end point was OS. The median OS was 5.2 months with ramucirumab compared with 3.8 months with placebo (P <.001). Ramucirumab also improved patients’ PFS compared with placebo.
Results from a second clinical trial of ramucirumab plus paclitaxel versus paclitaxel alone also showed an OS improvement with the addition of ramucirumab.
Common adverse events reported with ramucirumab include diarrhea and high blood pressure. The recommended dose of ramucirumab is 8 mg/kg every 2 weeks administered as an intravenous infusion over 60 minutes until disease progression or unacceptable toxicity.