FDA Approves Drug for Chemotherapy-Related Nausea

Varubi prevents nausea and vomiting associated with vomit-inducing cancer chemotherapy.

The FDA on Wednesday approved a new option for patients with cancer who suffer from sickness caused by chemotherapy.

Rolapitant (Varubi) prevents delayed phase nausea and vomiting associated with chemotherapy during cancer treatment. Varubi is administered in tablet form to adults in combination with other antiemetic agents to prevent nausea and vomiting from initial and repeat courses of emetogenic and highly emetogenic cancer chemotherapy.

“Chemotherapy-induced nausea and vomiting remains a major issue that can disrupt patients' lives and sometimes their therapy,” said Amy Egan, MD, MPH, deputy director of the Office of Drug Evaluation III in the Center for Drug Evaluation and Research. “Today’s approval provides cancer patients with another treatment option for the prevention of the delayed phase of nausea and vomiting caused by chemotherapy.”

Nausea and vomiting can last from 24 hours to up to 120 hours following the start of chemotherapy, which can result in weight loss, dehydration, and malnutrition. Varubi was approved as a substance P/neurokinin-1 (NK-1) receptor antagonist. NK-1 receptors activate to play the main role in sickness from certain cancer chemotherapies, specifically in the delayed phase.

Varubi inhibits the CYP2D6 enzyme responsible for metabolizing certain drugs. Varubi is contraindicated with the drug thioridazine because use of the 2 drugs together could increase the amount of thioridazine in the blood, which can cause a potentially serious abnormal heart rhythm.

The approval of Varubi followed 3 randomized, double-blind, controlled clinical trials. The drug was found to be safe and effective in combination with granisetron and dexamethasone compared with a control therapy of placebo, granisetron and dexamethasone.

The combination of Varubi, granisetron, and dexamethasone was administered to 2800 patients on a chemotherapy regimen with highly emetogenic drugs, such as cisplatin and the combination of anthracycline and cyclophosphamide, and moderately emetogenic chemotherapy drugs. Patients treated with Varubi experienced a greater decrease in vomiting and rescue medication usage for nausea and vomiting during the delayed phase compared with patients who received the control therapy.

Common side effects from Varubi include a neutropenia, hiccups, loss of appetite, and dizziness.