Varubi approved for chemotherapy-induced emesis

Sep-2015

The United States Food and Drug Administration (USFDA) has approved Varubi (Rolapitant) to prevent delayed-phase chemotherapy-induced nausea and vomiting. Varubi is indicated as a combined therapy with other anti-emetics as repeat course to counter emetogenic cancer chemotherapy. Varubi is to be marketed as tablet form by Tesaro Inc.

Varubi inhibits substance P/neurokinin-1 (NK-1) receptor activation of NK-1 receptors which play a vital role in nausea/vomiting induced by certain emetogenic chemotherapies.

Three randomized, double-blinded, controlled studies were conducted to assess the safety and efficacy of Varubi as a combined therapy with Granisetron and Dexamethasone. The study included 2800 patients to receive chemotherapy regimen including Anthracycline, Cyclophosphamide and Cisplatin.

Reduced incidence of vomiting and use of rescue drug to treat nausea and vomiting was reported in Varubi-treated patients, compared to control group subjects.

Some of the common adverse events of Varubi were neutropenia, dizziness, hiccups and decreased appetite.