The Food and Drug Administration has approved rolapitant for use in adults undergoing initial and repeat courses of chemotherapy to prevent nausea and vomiting, and it can be used in combination with other antiemetic agents that patients are also taking.

The approval comes after three randomized, double-blind, controlled clinical trials in which 2,800 patients were given either rolapitant or a placebo in combination with granisetron and dexamethasone. All patients were already receiving a chemotherapy regimen of highly or moderately emetogenic chemotherapy drugs, such as cisplatin, anthracycline, and cyclophosphamide. Those taking rolapitant had significantly reduced rates of emesis than those in the control cohort.

The drug, marketed as Varubi by Waltham, Massachusetts–based Tesaro Inc., is taken in tablet form and acts as a substance P/neurokinin 1–receptor antagonist to block emesis caused by chemotherapy.

“Chemotherapy-induced nausea and vomiting remains a major issue that can disrupt patients’ lives and sometimes their therapy,” said Dr. Amy Egan, deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, 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.”

Rolapitant is contraindicated for use with thioridazine, a drug which uses the CYP2D6 enzyme to metabolize – an enzyme which rolapitant inhibits. Taking both drugs together could cause arrhythmia. The most common side effects reported in patients taking rolapitant were neutropenia, decreased appetite, dizziness, and hiccups.

Serious adverse events associated with Varubi should be reported to the FDA’s MedWatch program at 800-332-1088 or www.fda.gov/Safety/MedWatch/default.htm.

dchitnis@frontlinemedcom.com

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