FDA Issues Approval for Varubi to Treat Chemotherapy Side Effects
A new option for patients suffering the side effects of chemotherapy will be coming soon to market.
This week, the U.S. Food and Drug Administration (FDA) approved Varubi, a drug designed to prevent delayed phase chemotherapy-induced nausea and vomiting. It is approved in adults in combination with other drugs that prevent nausea and vomiting associated with initial and repeat courses of vomit-inducing cancer chemotherapy.
"Chemotherapy-induced nausea and vomiting remains a major issue that can disrupt patients' lives and sometimes their therapy,"Amy Egan, deputy director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research said in a written statement. "Today's approval provides cancer patients with another treatment option for the prevention of the delayed phase of nausea and vomiting caused by chemotherapy."
The safety and efficacy of Varubi were established in three randomized, double-blind, controlled clinical trials where Varubi in combination with granisetron and dexamethasone was compared with a control therapy in 2,800 patients. Those patients treated with Varubi 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 Varubi include a low white blood cell count (neutropenia), hiccups, decreased appetite and dizziness.
Varubi is marketed by Tesaro Inc.