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FDA approves Cinvanti for chemo-induced nausea and vomiting


 


The Food and Drug Administration has approved aprepitant injectable emulsion for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV), Heron Therapeutics announced Nov. 9.

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The approval was based on data from two pivotal randomized cross-over bioequivalence studies that demonstrated bioequivalence of aprepitant injectable emulsion to fosaprepitant. Further, patients on aprepitant injectable emulsion reported fewer adverse events, 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,” Heron CEO Jeffrey Patton, MD, said in a statement. “NK1 receptor antagonists are recommended for routine use with [highly emetogenic chemotherapy] and are a recommended option with [moderately emetogenic chemotherapy]. Despite this, NK1 receptor antagonists are underutilized in CINV.”

Aprepitant injectable emulsion is indicated specifically for acute and delayed nausea and vomiting associated with initial and repeated courses of highly emetogenic chemotherapy, including high-dose cisplatin. Treatment is a single dose of 130 mg via intravenous infusion on day 1, approximately 30 minutes before chemotherapy is initiated. It is also indicated for use in moderately emetogenic chemotherapy; treatment of these patients is 100 mg on day 1, followed by oral aprepitant on days 2 and 3.

The most common adverse reactions with single-dose aprepitant injectable emulsion were headache and fatigue.

Aprepitant injectable emulsion will be marketed as Cinvanti and is expected to be available in January 2018, according to the company.
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