“The US Food and Drug Administration has approved the first single-dose intravenous NK1 receptor antagonist, fosaprepitant dimeglumine (Emend), for the treatment of nausea and vomiting that can accompany the use of moderately and highly emetogenic chemotherapy. The drug is approved in combination with other antiemetics.
“ ‘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, in a statement. ‘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.’ “
“In a phase III study reported in The Lancet Oncology, Schwartzberg et al found that the addition of rolapitant to serotonin (5-HT3) receptor antagonist and dexamethasone treatment significantly improved complete response rates in prevention of chemotherapy-induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy or anthracycline and cyclophosphamide regimens.
“In this double-blind trial, patients from 170 sites in 23 countries were randomly assigned between March 2012 and September 2013 to receive oral rolapitant 180 mg or placebo 1 to 2 hours before the administration of moderately emetogenic chemotherapy. All patients received oral granisetron 2 mg and oral dexamethasone 20 mg on day 1 (except for those receiving taxanes, who received dexamethasone according to the package insert) and granisetron 2 mg on days 2 and 3. Treatment was given for up to six cycles, with a minimum of 14 days…
“The investigators concluded: ‘Rolapitant in combination with a 5-HT3 receptor antagonist and dexamethasone is well tolerated and shows superiority over active control for the prevention of chemotherapy-induced nausea and vomiting during the 5-day (0–120 h) at-risk period after administration of moderately emetogenic chemotherapy or regimens containing an anthracycline and cyclophosphamide.’ “