FDA approves Varubi for chemotherapy-induced nausea

September 8, 2015

FDA has approved rolapitant (Varubi, Tesaro) for the prevention of chemotherapy-induced nausea and vomiting.

FDA has approved rolapitant (Varubi, Tesaro) for the prevention of chemotherapy-induced nausea and vomiting.

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Chemotherapy-induced nausea and vomiting (CINV) is a debilitating, yet often preventable, side effect for patients undergoing chemotherapy for cancer. It occurs in up to 90% of patients. There are 2 main types of CINV. Acute CINV occurs within the first 24 hours after receiving chemotherapy and delayed CINV, which can occur 24 hours to several days after treatment. Prolonged nausea and vomiting can lead to weight loss, dehydration, malnutrition, and other potentially serious health complications.

Varubi is a substance P/neurokinin-1 (NK-1) receptor antagonist. Substance P is a neurokinin that binds to NK-1 receptors, which are highly concentrated in the vomiting center of the brain. Activation of these receptors by Substance P plays a key role in eliciting CINV, particularly in the delayed phase. By blocking the binding of Substance P to the NK-1 receptor, Varubi acts to prevent CINV.

Varubi is approved, in combination with other antiemetic agents, in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. Varubi is currently only available in tablet form, but an intravenous formulation also is being developed.

Related:FDA approves antiemetic agent for prevention of chemotherapy-induced nausea and vomiting

“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 FDA's Center for Drug Evaluation and Research. “[The] 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 demonstrated in 3 randomized, double-blind, controlled trials in which Varubi, in combination with granisetron and dexamethasone, was compared to a control therapy of placebo plus granisetron and dexamethasone. The trials included 2,800 patients who were undergoing a regimen that included highly emetogenic and moderately emetogenic chemotherapy agents. Patients treated with Varubi showed a greater reduction in vomiting and use of rescue medication for nausea and vomiting during the delayed phase compared to the control group.

Varubi is a CYP2D6 inhibitor and is specifically contraindicated with the use of thioridazine, as using the 2 together may increase amounts of thioridazine and cause an abnormal heart rhythm. Neutropenia, hiccups, decreased appetite, and dizziness are the most common side effects associated with the use of this drug.

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