Ramucirumab granted priority review for gastric cancer by FDA


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The stomach cancer community has seen incremental progress over the past year, but the next advancement in treatment research appears to be ramucirumab, a drug that works by cutting off the blood supply to a tumor. Phase 3 study results, published last month in The Lancet, show that patients with gastric or gastroesophageal junction cancers that had progressed on first-line chemotherapy lived longer on the drug than on placebo (5.2 months versus 3.8 months). It also delayed disease progression. Side effects included high blood pressure and abdominal pain. Based on these results from the REGARD study, the Food and Drug Administration granted ramucirumab priority review on Oct. 23, which means the agency will make a decision in six months. Typically, it could take up to 10 months for review without the designation. Laura Goff, a gastrointestinal oncologist at Vanderbilt-Ingram Cancer Center in Nashville, Tenn., says it's likely the drug will be approved because the study showed a small but real improvement in survival in patients taking the drug compared with supportive care, such as pain medication and anti-emetics. "Helping patients live longer is a very real benefit. However, the question of how much longer is what often spurs debate. On average, the group taking the drug lived about a month and a half longer than the group not taking the drug. Therefore, the treatment group did better, but not a lot better," she says. "The good thing is that there were very few side effects."Currently, there is no approved treatment once the cancer has progressed on initial therapy, which means the investigational drug fulfills an unmet need--a requirement for the priority review designation. The FDA seems to be on a roll lately, so a decision may come even earlier. However, Goff says there are other chemotherapies that have been shown to be helpful in this setting. "Going forward, in order to recommend to my patients, I will need to see what the FDA approval looks like. Also, since this drug is a monoclonal antibody, I would anticipate that it would be very expensive," she says.While the REGARD study looked at ramucirumab used alone, the phase 3 RAINBOW trial is combining ramucirumab with paclitaxel to hopefully further extend survival without increasing side effects. "I am very interested in seeing the results of this agent when given in combination with chemotherapy to see what magnitude of benefit is achieved," Goff concluded.The drug is also being examined in lung, colorectal and liver cancers.Update: This blog was updated on Nov. 19 to include an email interview with gastrointestinal oncologist Laura Goff.

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