Rolapitant NDA Submitted for Chemotherapy-Induced Nausea and Vomiting

OPKO Health announced that its licensee, Tesaro Inc. has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of oral rolapitant, an investigational neurokinin-1 (NK-1) receptor antagonist in development for the prevention of chemotherapy-induced nausea and vomiting (CINV).

RELATED: Gastrohepatic Disorders Resource Center

The NDA submission for rolapitant is supported by data from four controlled studies with patients receiving chemotherapy known to commonly cause nausea and vomiting. The top-line results for three of the Phase 3 studies were previously announced.

For more information visit Opko.com or Tesarobio.com.

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