FDA Approves New Agent to Prevent Delayed Nausea in Patients Receiving Emetogenic Chemotherapy

The U.S. Food and Drug Administration (FDA) approved single-dose fosaprepitant dimeglumine injection in combination with other anti-emetic agents for the prevention of delayed nausea and vomiting in adults receiving initial and repeated courses of moderately emetogenic chemotherapy (MEC). Fosaprepitant dimeglumine has been previously approved for use in adults receiving highly emetogenic chemotherapy (HEC), making it the first U.S.-approved treatment for both MEC and HEC. The drug has not been studied in established nausea and vomiting.

The drug’s approval was based on the results from a randomized, parallel, double-blind, active comparator-controlled, phase III trial that compared outcomes between 502 patients treated with 150 mg fosaprepitant dimeglumine injection in combination with ondansetron and dexamethasone and 498 patients treated with ondansetron and dexamethasone alone (control). Among patients treated with fosaprepitant dimeglumine, 78.9 percent achieved a complete response (defined as no vomiting and no use of rescue therapy, in the delayed phase of chemotherapy-induced nausea and vomiting) compared with 68.5 percent in the control group (p<0.001).

The most common treatment-related adverse events associated with fosaprepitant dimeglumine included 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 (1%).

Source: Merck press release, February 4, 2016.