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FDA approves Stivarga to treat metastatic colorectal cancer
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The FDA today approved multikinase inhibitor regorafenib as a treatment for metastatic colorectal cancer that has been unresponsive to prior therapy, according to a press release.
Approval for regorafenib (Stivarga, Bayer HealthCare Pharmaceuticals) was issued through the agency’s priority review program, a month ahead of the scheduled review completion date of Oct. 27.
“Stivarga is the latest colorectal cancer treatment to demonstrate an ability to extend patients’ lives and is the second drug approved for patients with colorectal cancer in the past 2 months,” Richard Pazdur, MD, director of the FDA Center for Drug Evaluation and Research Office of Hematology and Oncology Products, said in the release. The agency approved ziv-aflibercept (Zaltrap, Sanofi-Aventis) for treatment of metastatic colorectal cancer combined with FOLFIRI chemotherapy in August.
Results from a randomized, 760-patient clinical study of regorafenib indicated that participants who received the drug in addition to supportive care survived longer than those who received placebo (median of 6.4 months vs. 5 months), according to the release. Treated patients also experienced longer PFS (median of 2 months vs. 1.7 months).
Upon release, Stivarga will include a boxed warning for severe and fatal liver toxicity, which occurred in treated patients during clinical trials. Other potential adverse events include fatigue, hand-foot syndrome, diarrhea, mouth sores, infection, high blood pressure and dysphonia.
Perspective
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David H. Ilson, MD, PhD
Regorafenib (Stivarga, Bayer) is an oral, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor that also targets other tyrosine kinases, including RAF. It is the first VEGF-targeted agent to improve survival in metastatic colorectal cancer as a single agent.
The CORRECT trial, which compared regorafenib with placebo, was conducted essentially in patients who have failed all chemotherapies and had no treatment options. The agent opens up a new avenue of treatment for patients with refractory colorectal cancer.In conjunction with recent data, the data for regorafenib suggest that continued suppression of VEGF pathways into multiple lines of therapy conveys a survival benefit in patients with colorectal cancer. The VELOUR trial, which validated survival benefit for the VEGF ligand trapping agent aflibercept (Zaltrap, Sanofi-Aventis), and the TML trial, which indicated survival benefits for continuation of bevacizumab (Avastin, Genentech) into second-line therapy beyond progression on first-line therapy, underscore this theme.
There is going to be a lot of interest in looking at regorafenib in earlier lines of therapy either as a single-agent or in combination with other chemotherapy regimens. I think it will stimulate interest in studying this drug in other gastrointestinal cancers, as well. It is a very exciting development and a significant advance.
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Tanios Bekaii- Saab, MD
We anticipated the approval of regorafenib (Stivarga, Bayer) by the FDA without concerns. The study has been in the public eye for a few months, including a recent presentation at ASCO. This is now the second approval in the last two months for advanced colorectal cancer. In August, the FDA approved ziv-aflibercept (Zaltrap, Sanofi-Aventis) for use in combination with folinic acid, fluorouracil and irinotecan (FOLFIRI) chemotherapy in patients with colorectal cancer.
The interesting thing about regorafenib is that, unlike all other approved biologic agents for colorectal cancer, this is the first oral targeted treatment approved by the FDA. The other interesting finding about this agent is that, unlike other vascular endothelial growth factor (VEGF) inhibitors, it has single-agent activity in colorectal cancer. This is probably explained by the fact that it is a multikinase inhibitor targeting VEGF and numerous other targets on the cancer cell and its microenvironment.
Overall, the approval of regorafenib continues to help expand the therapeutic arsenal in colorectal cancer. However, I think it is crucial for us to find a biomarker to better select patients who will respond to regorafenib given its potential cost and toxicities.
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