Multikinase inhibitor blocks enzymes that promote cancer
A new drug has been approved by the FDA for patients with colorectal cancer that has metastasized after treatment.
Stivarga (regorafenib) is a multikinase inhibitor that blocks several enzymes that promote cancer growth. Reviewed under the FDA’s priority review program, regorafenib is being approved 1 month ahead of the product’s prescription drug user fee goal date.
“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 two months,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research.
Regorafenib was evaluated in a single clinical study of 760 patients with previously treated metastatic colorectal cancer. Randomly assigned to receive regorafenib or placebo in addition to best supportive care (BSC), patients received treatment until their cancers progressed or side effects became unacceptable.
Study results showed patients treated with regorafenib plus BSC lived a median of 6.4 months and experienced a delay in tumor growth for a median of 2 months. Comparatively, patients treated with placebo plus BSC lived a median of 5 months and experienced progression-free survival for a median of 1.7 months.
Regorafenib is being approved with a Boxed Warning alerting patients and healthcare professionals that severe and fatal liver toxicity occurred in patients treated with regorafenib during clinical studies. The most common side effects reported in patients treated with regorafenib include weakness or fatigue, loss of appetite, hand-foot syndrome, diarrhea, mucositis, weight loss, infection, high blood pressure, and dysphonia.
Source: FDA.