Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions
Varubi Approved for Delayed Nausea and Vomiting
Tesaro news release; 2017 Oct 25
The FDA has approved Varubi (rolapitant) IV in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting caused by chemotherapy.
Indications: Varubi is a substance P/neurokinin 1 receptor antagonist indicated 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 highly emetogenic chemotherapy.
Dosage and administration:
- Tablets: 180 mg as a single dose.
- Injectable emulsion: 166.5 mg administered as an intravenous infusion over 30 minutes.
Efficacy and safety: Approval is based on results from 3 phase 3 studies showing superiority with Varubi when used with highly- and moderately- emetogenic chemotherapy regimens.
Side effects/risks: The most common adverse reactions with:
- Cisplatin-based highly emetogenic chemotherapy: neutropenia and hiccups.
- Moderately emetogenic chemotherapy and combinations of anthracycline and cyclophosphamide: decreased appetite, neutropenia and dizziness.
Tesaro announces US FDA approval of Varubi IV for delayed nausea and vomiting associated with cancer chemotherapy. [news release]. Waltham, MA: Tesaro, Inc. October 25, 2017. http://ir.tesarobio.com/news-releases/news-release-details/tesaro-announces-us-fda-approval-varubir-iv-delayed-nausea-and?_ga=2.162121727.216904064.1509119944-260390720.1509119944. Accessed October 29, 2017.
Varubi [package insert]. Waltham, MA: Kite Tesaro, Inc. 2017. http://www.varubirx.com/application/files/9515/0897/2736/VARUBI_rolapitant_Full_Prescribing_Information-October2017.pdf. Accessed October 29, 2017.
This Week's Must Reads
Must Reads in FDA Actions
Stereotactic Radiotherapy System Approved For BC, FDA news release; 2017 Dec 22
Perjeta Approved for Certain Type of Early BC, Genentech news release; 2017 Dec 20
Bosulif Approved to Treat Newly-Diagnosed Ph+ CML, Avillion news release; 2017 Dec 19
FDA Approves Nucala to Treat Vasculitis, FDA news release; 2017 Dec 12
FDA Approves Hemlibra to Prevent Bleeding, FDA news release; 2017 Nov 9