FDA Approves Varubi for Chemo-Induced Nausea and Vomiting

Tesaro, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved rolapitant (Varubi) in combination with other antiemetic agents for the prevention of delayed nausea and vomiting associated with initial and subsequent courses of emetogenic cancer chemotherapy in adults.¹ 

“While important strides in preventing nausea and vomiting associated with chemotherapy have been made, still up to half of patients receiving emetogenic cancer chemotherapy can experience delayed CINV [chemotherapy-induced nausea and vomiting],” said Richard J. Gralla, MD, professor of medicine at Albert Einstein College of Medicine in New York, NY. 

Rolapitant is a selective and competitive human substance P/neurokinin 1 (NK-1) receptor antagonist. Three phase 3 trials of rolapitant have demonstrated a significant reduction in episodes of vomiting or use of rescue medication during the 25- to 120-hour period (delayed phase) following administration of highly and moderately emetogenic chemotherapy.

Patients who received rolapitant also reported less nausea that impacted their daily life and fewer episodes of vomiting and retching over multiple chemotherapy cycles.

“Because NK-1 receptors are key drivers of CINV, especially in the delayed phase, NK-1 receptor antagonists such as Varubi, when combined with a 5-HT3 receptor antagonist and a corticosteroid, provide enhanced protection from CINV, and do so in the delayed timeframe where the most help is needed,” Dr. Gralla said.

Rolapitant is to be administered at a dose of 180 mg about 1 to 2 hours prior to chemotherapy administration in combination with a 5-HT3 receptor antagonist and dexamethasone.

In regard to safety, the most common adverse events associated with rolapitant were decreased appetite, neutropenia, dizziness, dyspepsia, urinary tract infection, stomatitis, and anemia.

Clinicians should be aware the rolapitant is contraindicated in patients receiving thioridazine and should be avoided in patients who are receiving pimozide.

Reference

1. Tesaro announces U.S. FDA approval of Varubi (rolapitant) for nausea and vomiting associated with cancer chemotherapy [news release]. Waltham, MA: Tesaro, Inc. http://ir.tesarobio.com/releasedetail.cfm?ReleaseID=929869.