The Food and Drug Administration has approved the use of Cyramza (ramucirumab) in combination with paclitaxel to treat patients with advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose cancer has progressed after treatment with fluoropyrimidine- or platinum-containing chemotherapy.
Cyramza-an angiogenesis inhibitor that blocks the blood supply to tumors-is now the only FDA-approved second-line treatment option for patients with advanced or metastatic gastric or GEJ adenocarcinoma whose disease has progressed on or after prior chemotherapy, notes a news release from the manufacturer, Eli Lily.
The drug has also been granted Orphan Drug Designation by the FDA for this indication. Orphan drug status is given in the U.S. by the FDA's Office of Orphan Products Development to medicines that show promise for the treatment of rare diseases. Cyramza was first approved earlier this year for the treatment of patients with advanced stomach cancer or GEJ adenocarcinoma (OT 5/25/14 issue).
The approval for this indication for Cyramza is based on data from the Phase III RAINBOW trial, which included 665 patients from 27 countries with locally advanced or metastatic gastric or GEJ adenocarcinoma whose cancer had progressed after fluoropyrimidine- and platinum-containing chemotherapy. The patients were randomized to receive Cyramza plus paclitaxel or placebo plus paclitaxel.
Median overall survival for patients receiving the Cyramza combination was 9.6 months compared with 7.4 months for those receiving placebo plus paclitaxel. Progression-free survival for patients receiving Cyramza was 4.4 months, compared with 2.9 months for those receiving the placebo.
The most common adverse events for patients who received Cyramza in the trial were fatigue, neutropenia, diarrhea, and epistaxis. The most common serious events were neutropenia and febrile neutropenia. And, 19 percent of patients treated with Cyramza received granulocyte colony-stimulating factors as treatment for low white blood cells.
The labeling for Cyramza contains a Boxed Warning for hemorrhage and additional Warnings and Precautions for arterial thromboembolic events, hypertension, infusion-related reactions, gastrointestinal perforations, impaired wound healing, clinical deterioration in patients with Child-Pugh B or C cirrhosis, and reversible posterior leukoencephalopathy syndrome.