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Intravenous Rolapitant Approved by FDA for Delayed Chemotherapy-Induced Nausea and Vomiting

By: Sarah Jackson
Posted: Friday, October 27, 2017

On October 25, 2017, the U.S Food and Drug Administration (FDA) approved intravenous (IV) rolapitant (Varubi) in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, according to an announcement by Tesaro. Delayed nausea and vomiting can occur anytime between 25 and 120 hours after chemotherapy. Oral olapitant was approved in this patient population in September 2015.

The efficacy of rolapitant, an antagonist of human substance P/neurokinin 1 receptors, was established in multiple randomized double-blinded clinical trials that enrolled more than 2500 patients. When administered in combination with a serotonin type 3 (5-HT3) receptor antagonist and dexamethasone, rolapitant was superior to a 5-HT3 receptor antagonist and dexamethasone alone in preventing delayed chemotherapy-induced nausea and vomiting in patients receiving either moderately or highly emetogenic chemotherapy.

The safety profile with IV rolapitant was consistent with that reported in previous clinical trials with oral rolapitant, except for infusion-site reactions noted with the IV formulation. Administered up to 2 hours before chemotherapy in combination with a 5-HT3 receptor antagonist and dexamethasone, IV rolapitant is supplied in ready-to-use vials that do not require refrigeration or mixing.