The Lynx Group

Regorafenib Latest Therapy Approved for Metastatic Colorectal Cancer

October 2012, Vol 3, No 7

Using its priority review process, the US Food and Drug Administration (FDA) approved the oral multikinase inhibitor regorafenib (Stivarga; Bayer HealthCare Pharmaceuticals) for the treatment of patients with metastatic colorectal cancer (mCRC).

“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,” said Richard Pazdur, MD, Director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. Colorectal cancer (CRC) is the third most common cancer and the third leading cause of cancer-related death among US adults; an estimated 51,690 people will die from CRC in 2012.

The approval of regorafenib was based on the safety and efficacy data in a single clinical trial of 760 patients with previously treated mCRC. The patients were randomized to regorafenib best supportive care (BSC) or to placebo plus BSC until disease progression or until side effects became unacceptable.

Regorafenib plus BSC was associated with a significantly longer overall survival (OS) versus placebo plus BSC (hazard ratio [HR] 0.77; 95% confidence interval [CI], 0.64-0.94; P = .010); median OS was 6.4 months versus 5.0 months, respectively. Progression-free survival (PFS) was also significantly improved with regorafenib; HR 0.49 (CI, 0.42-0.58; P <.001). The median PFS was 2.0 months with regorafenib versus 1.7 months with placebo.

The most frequently reported (≥30%) adverse events (AEs) with regorafenib were asthenia/fatigue, decreased ap­petite and food intake, hand-foot skin reaction, diarrhea, mucositis, weight loss, infection, hypertension, and dysphonia; the most serious AEs were hepatotoxicity, hemorrhage, and gastrointestinal perforation.

The recommended dosing for regorafenib is 160 mg (ie, 4 tablets of 40 mg each) once daily for the first 21 days of a 28-day cycle.

Regorafenib carries a Boxed Warning potential for severe and fatal liver tox­icity that had occurred in patients using this drug. (September 27, 2012)

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