Merck announced results from a global, investigational Phase 3 study to evaluate the safety and efficacy of EMEND (aprepitant) in the prevention of chemotherapy-induced nausea and vomiting (CINV) in pediatric cancer patients, aged six months to 17 years. In this study in pediatric cancer patients undergoing very highly, highly, or moderately emetogenic (vomit-inducing) chemotherapy, the use of the EMEND regimen for CINV prevention was significantly more effective than a control regimen in achieving Complete Response, defined as no vomiting or retching and no use of rescue medication for nausea and vomiting, in all phases of CINV (acute, delayed, and overall).
These new data were presented in an oral session at the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) Annual International Symposium on Supportive Care in Cancer by Dr. Hyoung Jin Kang, lead investigator and associate professor, Department of Pediatrics, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.
“Nausea and vomiting are common complications of cancer chemotherapy and can be particularly distressful and debilitating to pediatric cancer patients,” said Dr. Stuart Green, vice president, clinical research, Merck Research Laboratories. “In this large pediatric study, adding EMEND to a standard regimen for prevention of CINV resulted in significant reduction of emetic events.”
Based on these data, Merck plans worldwide regulatory submissions for EMEND (aprepitant), beginning in the United States, for use in the prevention of CINV in pediatric and adolescent cancer patients (ages six months to 17 years). In the United States, Merck plans to submit a New Drug Application (NDA) for a new pediatric formulation (powder for suspension) and a supplemental NDA for use of the current formulation (capsules). Both filings are planned for the second half of 2014.
EMEND, a Substance P/Neurokinin-1 (NK1) receptor antagonist approved for use in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy, including high-dose cisplatin; and for prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. EMEND has not been studied for treatment of established nausea and vomiting. Chronic continuous administration of EMEND is not recommended. Safety and efficacy of EMEND in pediatric patients have not been established.
Date: June 30, 2014