FDA approves advanced stomach cancer drug

FDA approved ramucirumab (Cyramza, Eli Lilly) to treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma.

Ramucirumab is a vascular endothelial growth factor (VEGF) Receptor 2 antagonist that blocks the blood supply to tumors. It is intended for patients with unresectable or metastatic stomach cancer, which has progressed after being treated with a fluoropyrimidine- or platinum-containing chemotherapy.

This year, more than 22,000 Americans will be diagnosed with stomach cancer and almost 11,000 will die from the disease, according to the National Cancer Institute.

“Until now, there were no FDA-approved options for patients with advanced gastric cancer after prior chemotherapy,” said Eli Lilly spokesperson Tracy J. Henrikson. “It is an aggressive disease that is difficult to treat, and the prognosis for these patients has typically been very poor. There is a high unmet medical need in patients with this disease. This approval represents a meaningful advance for patients with second-line gastric cancer and provides them an important new treatment option.”

The approval of ramucirumab is based on results of the REGARD study, which is the first phase 3 trial to show improved overall survival and progression-free survival with a biologic agent in advanced gastric cancer after prior chemotherapy. In the trial, both the median overall survival and progression-free survival improvements were statistically significant.

Study results showed participants treated with ramucirumab experienced a median overall survival of 5.2 months compared to 3.8 months in participants receiving placebo. Additionally, participants who took ramucirumab experienced a longer delay in tumor growth compared to participants who were given placebo. Results from a second clinical trial that evaluated the efficacy of ramucirumab plus paclitaxel versus paclitaxel alone also showed an improvement in overall survival. 

The most commonly reported adverse reactions in the study were hypertension and diarrhea. The labeling for ramucirumab contains a boxed warning regarding increased risk of hemorrhage. Physicians should evaluate any treatment option taking into account all efficacy and safety data. Ramucirumab is slowly infused into the vein; the infusion lasts approximately 60 minutes. Patients will usually receive the drug (8 mg/kg) once every 2 weeks.

 FDA reviewed ramucirumab under its priority review program. It was also granted orphan product designation because it is intended to treat a rare disease or condition.