Rolapitant (Varubi)

General information

Class/mechanism: Substance P/neurokinin 1 (NK1) receptor antagonist.
Route: PO, IV
Extravasation: n/a

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Patient drug information

History of changes in FDA indication

2015-09-01: Initial FDA approval "in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting sssociated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy."
2017-10-25: IV formulation FDA approved

History of changes in EMA indication

2017-04-20: Initial authorization as Varuby
2020-01-23: Withdrawn at the manufacturer's request, for commercial reasons

Pivotal studies

Rapoport BL, Chasen MR, Gridelli C, Urban L, Modiano MR, Schnadig ID, Poma A, Arora S, Kansra V, Schwartzberg LS, Navari RM. Safety and efficacy of rolapitant for prevention of chemotherapy-induced nausea and vomiting after administration of cisplatin-based highly emetogenic chemotherapy in patients with cancer: two randomised, active-controlled, double-blind, phase 3 trials. Lancet Oncol. 2015 Sep;16(9):1079-89. Epub 2015 Aug 10. PubMed
Schwartzberg LS, Modiano MR, Rapoport BL, Chasen MR, Gridelli C, Urban L, Poma A, Arora S, Navari RM, Schnadig ID. Safety and efficacy of rolapitant for prevention of chemotherapy-induced nausea and vomiting after administration of moderately emetogenic chemotherapy or anthracycline and cyclophosphamide regimens in patients with cancer: a randomised, active-controlled, double-blind, phase 3 trial. Lancet Oncol. 2015 Sep;16(9):1071-8. Epub 2015 Aug 10. PubMed

Also known as

Code names: SCH-619734
Brand names: Varubi, Varubi IV, Varuby