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FDA approves EMEND to prevent nausea, vomiting after moderately emetogenic chemotherapy
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The FDA approved use of single-dose fosaprepitant dimeglumine in combination with other antiemetic medicines for the prevention of delayed nausea and vomiting in patients who receive moderately emetogenic chemotherapy, the agent’s manufacturer announced today.
Fosaprepitant dimeglumine (EMEND, Merck) — a substance P/neurokinin-1 receptor (NK1) antagonist — already had been approved for highly emetogenic chemotherapy.
The FDA based its approval of the new indication on data from a randomized, double blind phase 3 study that showed a single IV infusion of fosaprepitant dimeglumine (EMEND, Merck) — a substance P/neurokinin-1 receptor (NK1) antagonist — in combination with ondansetron and dexamethasone offered better protection against delayed nausea and vomiting compared with ondansetron and dexamethasone alone.
Researchers reported a 78.9% complete response rate among 502 patients assigned the EMEND regimen, compared with a 68.5% complete response rate among 498 patients assigned the control regimen (P < .001).
Adverse reactions that occurred more commonly in the experimental regimen than the control regimen included fatigue (15% vs. 13%), diarrhea (13% vs. 11%), neutropenia (8% vs. 7%), asthenia (4% vs. 3%), anemia (3% vs. 2%) and peripheral neuropathy (3% vs. 2%).
EMEND is the first IV single-dose NK1 receptor antagonist approved in the United States for use with highly and moderately emetogenic chemotherapy.
“Despite significant advances in supportive care, nausea and vomiting has remained a challenge for many cancer patients undergoing moderately emetogenic chemotherapy — and has historically required multiday antiemetic therapy,” Stuart Green, vice president of clinical research for Merck Research Laboratories, said in a company-issued press release. “Today’s approval of an expanded indication for EMEND for injection means that physicians now have a new single-dose intravenous option, combined with other anti-vomiting medicines, for the prevention of delayed nausea and vomiting in these patients.”
The injection is contraindicated in patients who are hypersensitive to any component of the product. It also is contraindicated for patients who take pimozide.