On February 25, 2013 the FDA announced the approval of Stivarga (regorafenib) for the new indication of treatment of advanced gastrointestinal stromal tumors (GIST) that have progressed beyond treatment with surgery and do not respond to other treatments. Stivarga is a multi-kinase inhibitor that was initially approved for the treatment of metastatic colorectal cancer (CRC).
Stivarga may be used for GIST patients when the tumor has spread beyond the gastrointestinal tract and is unresponsive to treatment with Gleevec (imatinib) and Sutent (sunitinib), which are also approved for the treatment of GIST.
The safety and efficacy of Stivarga for this new indication was demonstrated through a clinical trial involving 199 GIST patients. Participants were assigned to receive treatment with Stivarga or placebo, until either the side effects were too severe or their cancer progressed. Those who were given Stivarga experienced 3.9 months of progression-free survival compared to the placebo group.
Gleevec (imatinib mesylate) is used to treat certain types of leukemia such as Philadelphia chromosome positive chronic myeloid leukemia (CML). It is also approved to treat certain tumors of the stomach and digestive system such as gastrointestinal stromal tumors (GISTs). Manufactured by Novartis, Gleevec was first approved on May 10, 2001.
FAERS data (from 11/01/1997 to 08/27/2012) was aggregated and standardized by the AdverseEvent RxFilter process. We identified 14,838 serious adverse events which listed Gleevec as a suspect drug, while 13,635 of these reports listed Gleevec as the primary suspect.
The most commonly reported side effects were death, neoplasm malignant, and nausea. We identified 4,142 hospitalizations and 4,862 patient deaths where Gleevec was determined to be the primary suspect.
Sutent (sunitinib) is a prescription medication used to treat advanced metastatic renal cell carcinoma (RCC), gastrointestinal stromal tumors (GIST), and progressive neuroendocrine cancerous tumors located in the pancreas that cannot be removed by surgery or that have spread to other parts of the body. Marketed by Pfizer, Sutent was first approved by the FDA on January 26, 2006 for the treatment of RCC and GIST. On May 20, 2011, the FDA approved Sutent to treat patients with progressive neuroendocrine cancerous tumors.
FAERS data (from 11/01/1997 to 08/27/2012) was aggregated and standardized by the AdverseEvent RxFilter process. We identified 13,180 serious adverse events which listed Sutent as a suspect drug, while 11,707 of these reports listed Sutent as the primary suspect.
The most commonly reported side effects were death, disease progression, and diarrhea. We identified 4,694 hospitalizations and 3,552 patient deaths where Sutent was determined to be the primary suspect.
Note: This analysis does not take into account the number of patients taking each medication.