The FDA approved rolapitant (Varubi, Tesaro) to prevent delayed chemotherapy-induced nausea and vomiting in adults. The new medication can be provided to patients in tablet form along 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, MD, MPH, the deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, said in a 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 FDA approval of the substance P/neurokinin-1 receptor antagonist was based on three randomized, double-blind, controlled clinical trials in which rolapitant in combination with granisetron and dexamethasone was compared with a control therapy (placebo, granisetron and dexamethasone) in 2,800 patients. All of the study’s participants received a chemotherapy regimen that included highly emetogenic (such as cisplatin and anthracycline-cyclophosphamide) and moderately emetogenic chemotherapy drugs. Those patients treated with rolapitant vomited less frequently and had a reduction in use of rescue medication for nausea and vomiting during the delayed phase compared with those receiving the control therapy, according to the press release.

Although rolapitant has met safety and efficacy standards, it inhibits the CYP2D6 enzyme and cannot be used with thioridazine, a drug metabolized by the CYP2D6 enzyme. Use of the two drugs together may increase the amount of thioridazine in the blood and cause an abnormal heart rhythm that can be serious.