The U.S. Food and Drug Administration (FDA) approved a supplemental new drug application for single-dose fosaprepitant dimeglumine (Emend), the intravenous formulation of aprepitant, in combination with other antiemetics for the prevention of delayed nausea and vomiting in adults receiving initial and repeat courses of moderately emetogenic chemotherapy (MEC).1
“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 multi-day antiemetic therapy,” said Stuart Green, vice president, clinical research, Merck Research Laboratories.
Approval of the substance P/neurokinin-1 receptor antagonist was based on findings from a phase 3 trial that demonstrated greater protection from delayed nausea and vomiting after MEC administration with fosaprepitant compared with an active control regimen.
A total of 1000 patients receiving MEC were randomly assigned to receive fosaprepitant 150 mg in combination with ondansetron and dexamethasone or ondansetron and dexamethasone alone. Results showed a 78.9% complete response rate with fosaprepitant vs 68.5% with the comparator during the 25- to 120-hour period following initiation of chemotherapy.
In terms of safety, the most adverse reactions reported in the fosaprepitant arm were fatigue (15%), diarrhea (13%), neutropenia (8%), asthenia (4%), anemia (3%), peripheral neuropathy (3%), leukopenia (2%), dyspepsia (2%), urinary tract infection (2%), and pain in extremity (2%).
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Fosaprepitant is now the first and only intravenous neurokinin-1 receptor antagonist approved in the United States for use in MEC as well as highly emetogenic chemotherapy (HEC).
“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,” Green said.
- FDA approves Merck’s single-Dose EMEND® (fosaprepitant dimeglumine) for injection, in combination with other antiemetic agents, for the prevention of delayed nausea and vomiting in adults receiving moderately emetogenic chemotherapy (MEC) [news release]. Kenilworth, NJ: Merck; February 4, 2016. http://www.mercknewsroom.com/news-release/corporate-news/fda-approves-mercks-single-dose-emend-fosaprepitant-dimeglumine-injectio. Accessed February 4, 2016.