You are here
IV Aprepitant Wins FDA Approval for Prevention of Acute and Delayed CINV
The FDA has approved aprepitant injectable emulsion (Cinvanti, Heron Therapeutics, Inc.) for intravenous (IV) infusion for treating acute and delayed chemotherapy-induced nausea and vomiting (CINV).
The agent, a substance P/neurokinin-1 (NK1) receptor antagonist, is indicated in adults, in combination with other antiemetic agents, for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC), including high-dose cisplatin, and nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).
Aprepitant injectable emulsion is the first and only polysorbate 80-free, IV formulation of an NK1 receptor antagonist indicated for the prevention of acute and delayed CINV, and is the first IV formulation to directly deliver aprepitant, the active ingredient in Emend capsules (Merck). Aprepitant (including its prodrug, fosaprepitant) is the only single-agent NK1 receptor antagonist to significantly reduce CINV in both the acute phase (0 to 24 hours after chemotherapy) and the delayed phase (24 to 120 hours after chemotherapy).
Aprepitant injectable emulsion does not contain polysorbate 80 or any other synthetic surfactant. Pharmaceutical formulations containing polysorbate 80 have been linked to hypersensitivity reactions, including anaphylaxis and irritation of blood vessels resulting in infusion-site pain.
The FDA approval was based on data demonstrating the bioequivalence of aprepitant injectable emulsion to IV fosaprepitant (Emend IV, Merck), supporting its efficacy for the prevention of acute and delayed CINV following HEC and MEC.
Results from two pivotal randomized, cross-over bioequivalence studies of aprepitant injectable emulsion and IV fosaprepitant showed patients receiving aprepitant injectable emulsion reported fewer adverse events than those receiving IV fosaprepitant, including substantially fewer infusion-site reactions.
“CINV remains a high unmet medical need in the oncology community, and five full days of CINV coverage continues to be our goal. NK1 receptor antagonists are recommended for routine use with HEC and are a recommended option with MEC. Despite this, NK1 receptor antagonists are underutilized in CINV. This provides a large opportunity for Cinvanti to help more patients avoid CINV and adhere to their chemotherapy regimens,” said Jeffrey F. Patton, MD, Chief Executive Officer of Tennessee Oncology.
Heron plans to launch the therapy in January 2018, according to a press release.
Source: Heron; November 9, 2017.