The Gastrointestinal Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) reviewed clinical data on Emend (aprepitant), Merck & Co Inc's investigational oral medicine for the prevention of highly emetogenic chemotherapy-induced nausea and vomiting. Highly emetogenic chemotherapy is treatment that would be expected to trigger vomiting in 90 per cent of patients who did not receive antiemetic (anti-vomiting) therapy.

The advisory committee unanimously agreed that Emend in combination with standard antiemetic therapy (a 5-HT3 receptor antagonist plus a corticosteroid) demonstrated efficacy in the prevention of nausea and vomiting in both the acute and delayed phase following highly emetogenic chemotherapy. The advisory committee recommended post-marketing studies to gather additional information about the safety profile of the Emend regimen in patients receiving certain chemotherapeutic agents.

The advisory committee was not asked to vote on whether it recommended Emend for approval. The committee reviewed efficacy and safety data from studies with Emend. The studies evaluated the combined regimen with Emend taken for three days in patients receiving highly emetogenic chemotherapy in preventing nausea and vomiting within the first 24 hours and up to five days following chemotherapy. The studies included patients who received Emend over multiple cycles of chemotherapy.

Nausea and vomiting are common and well-recognized complications of cancer chemotherapy that can lead to considerable distress and may even cause patients to consider stopping or delaying further cancer treatment. Currently, there is no antiemetic therapy indicated for nausea and vomiting in the delayed phase following highly emetogenic chemotherapy.