The U.S. Food and Drug Administration has approved the use of Cyramza (ramucirumab) to treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma. Cyramza, an angiogenesis inhibitor that blocks the blood supply to tumors, is intended for patients whose cancer is unresectable or metastatic after being treated with a fluoropyrimidine- or platinum-containing therapy.
“Although the rates of stomach cancer in the United States have decreased over the past 40 years, patients require new treatment options, particularly when they no longer respond to other therapies,” Richard Pazdur, MD, the FDA's Director of the Office of Hematology and Oncology Products, said in a news release.
The drug's approval was based on a clinical trial of 355 patients with unresectable or metastatic stomach or gastroesophageal junction cancer who received Cyramza or a placebo. Median overall survival for patients receiving Cyramza was 5.2 months compared with 3.8 months for patients receiving the placebo (OT 5/10/13 issue). And results from a second clinical trial evaluated the efficacy of Cyramza plus paclitaxel versus paclitaxel alone, which showed an increase in overall survival for the patients also receiving Cyramza (OT 2/25/14 issue).
Common side effects reported for the patients receiving Cyramza were diarrhea and high blood pressure.
The drug, marketed by Eli Lilly, was reviewed under the agency's priority review program, which provides for an expedited review of drugs that have the potential (at the time the application was submitted) to be a significant improvement in safety or effectiveness in the treatment of a serious condition (OT 11/25/13 issue). Cyramza was also granted orphan product designation because it is intended to treat a rare disease or condition.
Also newly approved is Sylvant (siltuximab) to treat patients with multicentric Castleman's disease (MCD), a rare immune disorder (similar to lymphoma) that causes an abnormal overgrowth of immune cells in lymph nodes and related tissues. Sylvant is an injection that works by blocking a protein that stimulates the abnormal immune cell growth, and it is intended for patients who do not have HIV or human herpes virus 8 (HHV-8).
“Sylvant is the first FDA-approved drug to treat patients with MCD,” Pazdur said in a news release. “The approval demonstrates the FDA's commitment to approving drugs for rare diseases.”
Sylvant was also reviewed under the FDA's priority review program, and had also been given Orphan Drug status.
The drug's safety and effectiveness were evaluated in a clinical trial of 79 patients with MCD who were HIV and HHV-8 negative, who were randomly assigned to receive either Sylvant and best supportive care or placebo and best supportive care. The results, reported at the most recent American Society of Hematology Annual Meeting, showed that 34 percent of the patients treated with Sylvant and best supportive care experienced tumor response, while no participants treated with placebo and best supportive care did (OT 4/10/14 issue).
Common side effects reported include pruritus, weight gain, rash, increased levels of uric acid in the blood, and upper respiratory tract infection.
Sylvant is marketed by Janssen Biotech Inc.