FDA Approves Single-Dose Fosaprepitant Print Email

US FDA Approves Single-Dose Fosaprepitant for CINV

February 2016
In February, 2016, the US Food and Drug Administration approved a single-use injection of fosaprepitant dimeglumine (Emend®) to prevent delayed nausea and vomiting in adults receiving an initial or repeat course of moderately emetogenic chemotherapy. The drug was already approved for highly emetogenic chemotherapy. The approval was based in part on a phase III trial comparing a single IV infusion (150 mg) of fosaprepitant dimeglumine in combination with ondansetron and dexamethasone with a control regimen ondansetron and dexamethasone alone. 

MASCC members Karin Jordan (of Martin Luther University, in Halle, Germany) and Bernardo Rapoport (The Medical Oncology Centre of Rosebank, Johannesburg, South Africa) were part of the research team that conducted this study, which is the first to assess the efficacy and safety of a single IV dose of fosaprepitant in a well-defined noncyclophosphamide MEC population. 

The fosaprepitant regimen was well tolerated and resulted in a complete response (no vomiting and no rescue medication) in nearly 79% in the delayed phase and 77% in the overall phase — both significantly greater rates than achieved with the control regimen. In the acute phase, both regimens resulted in a high rate of complete response. 

The results of the study, presented at the 2015 MASCC/ISOO Annual Meeting, as well as the 2015 meeting of the American Society of Clinical Oncology, were published in Annals of Oncology in January.

Weinstein C, Jordan K, Green SA, Camacho E, Khanani S, Beckford-Brathwaite E, Vallejos W, Liang LW, Noga SJ, Rapoport BL. Single-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapy: results of a randomized, double-blind phase III trial.  Ann Oncol. 2016 Jan;27(1):172-8. 

Free full text: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4684151/