Stivarga is a multi-tyrosine kinase inhibitor approved for third-line use after failure (or intolerance) of Gleevec and Sutent. The FDA approved this drug for the United States on February 25, 2013. As of 2017, it is also approved in more than 90 countries worldwide.
Stivarga is known by several different names:
- Stivarga, the brand name
- Regorafenib, the generic name
- BAY 73-4506, the name used in early clinical trials
Stivarga, manufactured by Bayer, comes in 40 mg tablets. Once opened, it must be used within 28 days. It is important to note that Stivarga must be stored in the bottle that it comes in, the desiccant must remain in the bottle; keep bottle tightly sealed. Do not store in a daily or weekly pill box. The standard dose for Stivarga is 160 mg for 21 days followed by 7 days without drug. This cycle is repeated as long as there is benefit. The dose may be lowered or temporarily stopped in cases of significant side effects.
A complete guide to dose modifications can by found in the Stivarga prescribing information.
How it Works
Stivarga is a multi-tyrosine kinase inhibitor. The most important thing for GIST patients is that it inhibits KIT, including many of the secondary mutations that develop over time and cause resistance to Gleevec and Sutent. In addition to KIT, it inhibits PDGFRA (important for a subset of GISTs), VEGF receptors and over a dozen other targets that are probably less important in GIST.
For information on side effects, click here.
Surgery and Stivarga
Stivarga and other drugs that inhibit the VEGF receptors can impair wound healing. Because of this, the FDA prescribing information recommends stopping Stivarga two weeks prior to any planned surgery. They further recommend that the decision to resume Stivarga after surgery should be based on clinical judgment of adequate wound healing.
Support and Assistance
Bayer Pharmaceuticals’ Resources for Expert Assistance and Care Helpline (REACH) program has helped many GIST patients access treatment. REACH fills the gap by helping patients appeal denials, offering prior authorization and co-payment assistance, to name a few of its services. REACH counselors can be accessed by calling 1-866-639-2827. The helpline receives as many as 5,000 calls per year and has helped over 200 patients in its free drug program.
In the event that a patient resides in a country Stivarga is not yet approved in, he/she may be able to access this drug through a clinical trial. Contact Bayer at: email@example.com for more information.
Stivarga website (Bayer)
Stivarga prescribing information (PDF)
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Prof George D Demetri MD, Prof Peter Reichardt MD, Prof Yoon-Koo Kang MD, Prof Jean-Yves Blay MD, Piotr Rutkowski MD, Hans Gelderblom MD, Prof Peter Hohenberger MD, Michael Leahy FRCP, Prof Margaret von Mehren MD, Prof Heikki Joensuu MD, Giuseppe Badalamenti MD, Martin Blackstein FRCP, Axel Le Cesne MD, Prof Patrick Schöffski MD, Prof Robert G Maki MD, Sebastian Bauer MD, Binh Bui Nguyen MD, Jianming Xu MD, Toshirou Nishida MD, John Chung MD, Christian Kappeler PhD, Iris Kuss MD, Dirk Laurent MD, Paolo G Casali MD, on behalf of all GRID study investigators. Efficacy and safety of regorafenib for advanced gastrointestinal stromal tumours after failure of imatinib and sunitinib (GRID): an international, multicentre, randomised, placebo-controlled, phase 3 trial. The Lancet – 22 November 2012. DOI: 10.1016/S0140-6736(12)61857-1.