FDA has approved Stivarga (regorafenib) to treat patients with metastatic colorectal cancer, according to a news release.
Stivarga, manufactured by Bayer HealthCare Pharmaceuticals, is a multi-kinase inhibitor that blocks several enzymes that promote cancer growth. The drug was reviewed under the FDA's priority review program, and was approved one month ahead of the product's prescription drug user fee goal 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 two months," said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in FDA's Center for Drug Evaluation and Research, in the release.
In August, FDA approved Zaltrap (ziv-aflibercept) for use in combination with a FOLFIRI (folinic acid, fluorouracil and irinotecan) chemotherapy regimen to treat adults with metastatic colorectal cancer.
Bayer HealthCare Pharmaceuticals is headquartered in Wayne, N.J.
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