The Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Emend (aprepitant; Merck) to include patients 12–17 years old and patients <12 years old who weigh ≥30kg for the prevention of chemotherapy-induced nausea and vomiting (CINV).
The FDA approval was based on data from a Phase 3 randomized, double-blind, active-comparator-controlled clinical study that studied Emend in combination with ondansetron (Emend regimen) vs. ondansetron alone (control regimen) for the prevention of CINV in patients 12–17 years old (n=63) and patients <12 years old weighing ≥30kg (n=69) receiving highly emetogenic or moderately emetogenic cancer chemotherapy. The primary endpoint was complete response (defined as no vomiting, retching, and no rescue medication use) in the delayed phase (25–120 hours following chemotherapy initiation).
Data showed that in the delayed phase, 49.2% complete response rate was seen in the Emend regimen group vs. 18.8% rate in the control regimen. In the acute phase, a 55.6% complete response seen in the Emend regimen vs. 37.7% in the control regimen. In the overall phase, a 34.9% complete response rate was seen in the Emend regimen vs. 13.0% in the control regimen.
Emend, a substance P/neurokinin 1 (NK1) receptor antagonist, is indicated in combination with other antiemetic agents to prevent acute and delayed nausea and vomiting associated with initial and repeat courses of moderately to highly emetogenic cancer chemotherapy, including high-dose cisplatin; and for the prevention of post-op nausea and vomiting.
For more information call (877) 888-4231 or visit Emend.com.