FDA approves Bayer’s colorectal cancer drug

Hannah Blake

pharmaphorum

The US FDA has approved Stivarga to treat patients with colorectal cancer, which has progress after treatment and spread to other parts of the body. Stivarga (regorafenib) is a multi-kinase inhibitor that blocks several enzymes that promote cancer growth.

The drug, joint marketed by Bayer HealthCare Pharmaceuticals Inc. and Onyx Pharmaceuticals, was reviewed under the FDA’s priority review program, which provides an expedited six-month review for drugs that offer major advances in treatment or that provide treatment when no adequate therapy exists.

“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.”

Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research.

Colorectal cancer is the third most common cancer in men and women. Approximately 143, 460 Americans will be diagnosed with this type of cancer in 2012, according to The National Institutes of Health.

Sanofi’s Zaltrap (ziv-aflibercept) is the other colorectal cancer drug approved in the past two months. It was approved for use in combination with a FOLFIRI (folinic acid, fluorouracil and irinotecan) chemotherapy regimen to treat adults with metastatic colorectal cancer.