The agency approved regorafenib (Stivarga, Bayer HealthCare Pharmaceuticals) under its priority review program. Approval came 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,” Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “[It] is the second drug approved for patients with colorectal cancer in the past 2 months.”
The FDA in August approved ziv-aflibercept (Zaltrap, Sanofi-Aventis) for treatment of metastatic colorectal cancer in combination with FOLFIRI chemotherapy.
The FDA based its approval of regorafenib on results of a randomized study that involved 760 patients.
The researchers assigned participants to regorafenib or placebo in addition to best supportive care. Treatment continued until their disease progressed or side effects became unmanageable.
Participants assigned to regorafenib demonstrated longer median OS (6.4 months vs. 5 months) and longer median PFS (2 months vs. 1.7 months) than those assigned to placebo, according to study results.
Upon release, the drug will include a boxed warning alerting patients and physicians that fatal liver toxicity occurred in some study participants treated with regorafenib.
The most common side effects reported in patients treated with the drug include fatigue, loss of appetite, hand-foot syndrome, diarrhea, mouth sores, infection, high blood pressure and dysphonia.
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