Trial Profile
An Open-Label, Randomized, Pivotal, Bioequivalence Study of Oral and Intravenous Rolapitant
Status:
Completed
Phase of Trial:
Phase I
Latest Information Update: 27 Oct 2017
Price :
$35
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At a glance
- Drugs Rolapitant (Primary) ; Rolapitant (Primary)
- Indications Chemotherapy-induced nausea and vomiting
- Focus Pharmacokinetics
- Sponsors TESARO
- 25 Oct 2017 According to a Tesaro media release, the U.S. Food and Drug Administration (FDA) has approved VARUBI (rolapitant) IV in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.
- 14 Sep 2017 Results published in the Journal of Clinical Pharmacology
- 11 Jan 2017 According to a Tesaro media release, the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the rolapitant IV New Drug Application (NDA) for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy.