FDA approves Varubi (rolapitant) for nausea and vomiting-Tesaro Inc

The FDA approved Varubi (rolapitant), from Tesaro Inc, to prevent delayed phase chemotherapy-induced nausea and vomiting (CINV). Varubi is approved in adults in combination with other drugs (antiemetic agents) that prevent nausea and vomiting associated with initial and repeat courses of emetogenic and highly emetogenic cancer chemotherapy.

The safety and efficacy of rolapitant were established in three randomized, double-blind, controlled clinical trials where rolapitant in combination with granisetron and dexamethasone was compared with a control therapy (placebo, granisetron and dexamethasone) in 2,800 patients receiving a chemotherapy regimen that included highly emetogenic (such as cisplatin and the combination of anthracycline and cyclophosphamide) and moderately emetogenic chemotherapy drugs. Those patients treated with rolapitant had a greater reduction in vomiting and use of rescue medication for nausea and vomiting during the delayed phase compared to those receiving the control therapy. The most common side effects in patients treated with rolapitant include a low white blood cell count (neutropenia), hiccups, decreased appetite and dizziness.