FDA Approves Intravenous Version of Tesaro Drug for Chemotherapy Nausea
By Reuters Staff
(Reuters) - Tesaro Inc said on Wednesday that the U.S. Food and Drug Administration approved an intravenous version of its drug to treat chemotherapy-induced nausea and vomiting in adults.
The intravenous version of the already-approved drug, Varubi, will be used in combination with other agents to prevent delayed nausea and vomiting associated with some forms of chemotherapy, the company said in a statement.
The oral version of Varubi was approved by the FDA in 2015.
The intravenous formulation will be launched in November and cost less than the oral drug, Tesaro's chief executive, Lonnie Moulder, told Reuters in an interview.
It will have a list price of $295 per ready-to-use vial, compared to $561.80 for the oral drug, Moulder said.
Chemotherapy-induced nausea and vomiting is considered one of the most acute side effects of cancer therapy and affects up to 80% of patients, according to the National Institutes of Health.
Varubi works by blocking the activation of neurokinin (NK)-1 receptors in the nervous system that play an important role in nausea and vomiting.
Other FDA-approved (NK)-1 receptor antagonist drugs to treat chemotherapy-induced nausea and vomiting include Merck & Co Inc's Emend, which had sales of $549 million last year.
Tesaro licensed Varubi from Opko Health Inc in December 2010.