Tesaro, Inc., announced that VARUBIT (rolapitant), an NK-1 receptor antagonist, is now available in the United States.
The FDA approved VARUBI on Sept. 1, 2015, for use 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 a selective and competitive antagonist of human substance P/neurokinin 1 (NK-1) receptors, with a plasma half-life of approximately seven days.
Results from all three Phase 3 trials of VARUBI demonstrated that patients receiving highly and moderately emetogenic chemotherapy agents, including platinum and anthracycline/cyclophosphamide-containing regimens, experienced a significant reduction in episodes of vomiting or use of rescue medication during the 25 to 120 hour period following chemotherapy administration. In addition, patients who received VARUBI reported experiencing less nausea that interfered with normal daily life and fewer episodes of vomiting or retching over multiple cycles of chemotherapy.
No dosage adjustment is required for dexamethasone, a CYP3A4 substrate, when administering VARUBI. A single dose (two 90 milligram tablets) of VARUBI is to be administered approximately one to two hours prior to chemotherapy administration, in combination with a 5-HT3 receptor antagonist and dexamethasone.
“We are proud to introduce our first product, VARUBI, for the prevention of delayed nausea and vomiting associated with cancer chemotherapy,” said Lonnie Moulder, CEO of Tesaro. “Many patients expect CINV to be a distressing part of chemotherapy, and their symptoms often occur outside of the clinic. As an NK-1 receptor antagonist, VARUBI works specifically to prevent CINV in the days after chemotherapy administration. By reducing the burden of delayed nausea and vomiting, we can help people who are undergoing chemotherapy spend time with their families and focus on what is most important to them.”
“VARUBI represents a meaningful option in cancer supportive care, for both patients and physicians,” said Lee S. Schwartzberg, M.D., F.A.C.P., executive director, West Cancer Center. “Blocking both 5-HT3 and NK-1 receptors has been shown to offer better control of nausea and vomiting than by inhibiting 5-HT3 receptors alone. Adding a single dose of VARUBI to an antiemetic regimen, including a 5-HT3 receptor antagonist and corticosteroid, may result in fewer episodes of vomiting or use of rescue medication, as well as less nausea that interferes with normal daily life in the days following chemotherapy. In addition, no dosage adjustment is required for dexamethasone, a CYP3A4 substrate, when administering VARUBI.”
Just three weeks after the approval of VARUBI by the U.S. FDA, the National Comprehensive Cancer Network (NCCN) added VARUBI to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) Antiemesis Version 2.2015 as a recommended option, in combination with other antiemetic agents, for patients receiving both high emetic risk intravenous chemotherapy (HEC) and moderate emetic risk intravenous chemotherapy (MEC). Category 1, the highest level category of evidence and consensus, was granted to VARUBI for both HEC and MEC chemotherapy.
The full prescribing information for VARUBI is available at www.VarubiRx.com.