FDA Approves Label Expansion for Single-Dose Regimen of Intravenous Aprepitant for Patients Receiving Moderately Emetogenic Chemotherapy
On October 22, the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) for aprepitant (Cinvanti) injectable emulsion for intravenous (IV) use. The sNDA requested FDA approval to expand the recommended dosage to include the 130-mg single-dose regimen for patients receiving moderately emetogenic chemotherapy.
The treatment is indicated for the prevention of acute and delayed chemotherapy-induced nausea and vomiting following both highly emetogenic chemotherapy and/or moderately emetogenic cancer chemotherapy. Aprepitant (including its prodrug, fosaprepitant) is the only single-agent substance P/neurokinin-1 receptor antagonist to significantly reduce chemotherapy-induced nausea and vomiting in both the acute phase (0–24 hours after chemotherapy) and the delayed phase (24–120 hours after chemotherapy).
Cinvanti was initially approved based on data demonstrating the bioequivalence of aprepitant to fosaprepitant (Emend IV), supporting its efficacy for the prevention of acute and delayed chemotherapy-induced nausea and vomiting following highly and moderately emetogenic chemotherapy. Results from two pivotal, randomized, crossover, bioequivalence studies of IV aprepitant and IV fosaprepitant showed subjects receiving aprepitant reported fewer adverse events than those receiving fosaprepitant, including substantially fewer infusion-site reactions.
In February 2019, the FDA approved an sNDA to expand the administration of Cinvanti beyond the already approved administration method (a 30-minute IV infusion) to include a 2-minute IV injection (or IV push). This 2-minute IV push for aprepitant was approved based on a third study demonstrating bioequivalence and a comparable safety profile to aprepitant given as a 30-minute IV infusion.
The aprepitant label expansion standardizes the 130-mg single-dose regimen for patients receiving highly and/or moderately emetogenic chemotherapy as an injection over 2 minutes or an infusion over 30 minutes, further simplifying dosing and administration and eliminating the need to take oral aprepitant on days 2 and 3 following chemotherapy administration. Furthermore, this label expansion builds on the prior label expansion that introduced the 2-minute IV push, which enables physicians to leverage the operational advantages of this method of administration and contributes to a reduction in total patient time spent at the infusion site.