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FDA approves Varubi for chemotherapy-induced nausea, vomiting
The FDA today approved rolapitant for the treatment of delayed-phase nausea and vomiting in patients with cancer who are undergoing chemotherapy.
Rolapitant (Varubi, Tesaro Inc.) — a substance P/neurokinin-1 (NK-1) receptor antagonist — is approved in combination with other antiemetic agents for adult patients with cancer who experience nausea and vomiting associated with initial and repeat courses of emetogenic and highly emetogenic chemotherapy.
Activation of NK-1 receptors play a key role in nausea and vomiting induced by certain chemotherapies, particularly in the delayed phase, or 24 to 120 hours after the start of chemotherapy.
The FDA based its decision to approve rolapitant in part on the results of three randomized, double-blind, controlled clinical trials of rolapitant in combination with granisetron and dexamethasone vs. a control therapy (placebo, granisetron and dexamethasone) for 2,800 patients receiving moderately and highly emetogenic chemotherapy drugs.
Rolapitant demonstrated a greater reduction in vomiting and use of rescue medication for nausea and vomiting during the delayed phase than the control therapies.
The most common side effects associated with rolapitant include neutropenia, hiccups, decreased appetite and dizziness.
Rolapitant is designed to inhibit the CYP2D6 enzyme, which is responsible for metabolizing certain drugs. Therefore, rolapitant is contraindicated with the use of thioridazine, a drug metabolized by CYP2D6, because these two drugs used together could potentially increase the amount of thioridazine in the blood and cause a serious abnormal heart rhythm.
“Chemotherapy-induced nausea and vomiting remains a major issue that can disrupt patients' lives and sometimes their therapy,” Amy Egan, MD, MPH, deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, said in a press release. “Today’s approval provides cancer patients with another treatment option for the prevention of the delayed phase of nausea and vomiting caused by chemotherapy.”