US FDA approves Tesaro’s chemotherapy anti-nausea drug

The approval is based on four trials of patients receiving emetogenic chemotherapy, including cisplatin, carboplatin and anthracycline/cyclophosphamide-based regimens.

Varubi is a selective and competitive antagonist of human substance P/neurokinin 1 (NK-1) receptors, with a plasma half-life of about seven days.

It is indicated in combination with other antiemetic agents in adults to avoid delayed nausea and vomiting related with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.

Results from three Phase 3 trials of the drug showed a reduced episodes of vomiting or use of rescue medication during the 25 to 120 hour period.

Patients who received the drug experienced less nausea that interfered with normal daily life and fewer episodes of vomiting or retching over various cycles of chemotherapy.

Tesaro said a 180 milligram dose of Varubi is to be administered about one to two hours before chemotherapy administration in combination with a 5-HT3 receptor antagonist and dexamethasone.

The company noted that no dosage adjustment is needed for dexamethasone, a CYP3A4 substrate, when administering the drug.

Tesaro CEO Lonnie Moulder said: "Results from the Phase 3 trials of Varubi demonstrated that patients receiving emetogenic chemotherapy agents, including platinum and cyclophosphamide-containing regimens, benefitted from the addition of Varubi to their antiemetic regimen.

"Data from multiple well-controlled trials demonstrate that patients who receive only a 5-HT3 receptor antagonist and dexamethasone often continue to suffer from nausea and vomiting for several days following chemotherapy administration."