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# Tesaro sNDA for Varubi IV Approved
- URL: https://www.fdaweb.com/tesaro-snda-for-varubi-iv-approved/
- Published: 2017-10-26T12:00:00.000Z
- Updated: 2026-09-14T22:58:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139970

FDA has approved a Tesaro supplemental NDA for Varubi (rolapitant) IV in combination with other antiemetic agents in adults for preventing delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic chemotherapy. Delayed nausea and vomiting can occur anytime between 25 and 120 hours following chemotherapy, and is often extremely debilitating, the company says.

Tesaro licensed the exclusive rights for developing and marketing Varubi from Opko Health in 2010\. It launched an oral version of the therapy in 2015.

The company describes Varubi as a highly selective and competitive antagonist of human substance P/neurokinin 1 (NK-1) receptors, which play an important role in the delayed phase of chemotherapy induced nausea and vomiting (CINV). “With a long plasma half-life of approximately seven days, a single dose of Varubi, as part of an antiemetic regimen, significantly improved complete response (CR) rates in the delayed phase of CINV,” it says.