Stivarga: Advanced Colon Cancer Drug Approved By FDA

By Bill Berkrot
Sept 27 (Reuters) - The U.S. Food and Drug Administration on Thursday approved a new drug for advanced colon cancer developed by Bayer AG a month ahead of the agency's expected action date for a decision.
The drug, to be sold under the brand name Stivarga, was approved to treat colon cancer that has progressed after prior treatment or that has spread to other parts of the body, the agency said.
"Someone has clearly lit a fire under the FDA," Sanford Bernstein analyst Geoffrey Porges said of the speedy approval. "We're seeing a fairly consistent pattern of drugs for high unmet needs diseases being approved on an expedited basis."
In pivotal clinical trials, Stivarga - known chemically as regorafenib - modestly extended survival and delayed disease progression. It helped patients live on average 1.4 months longer than those who received standard treatment without the Bayer drug.
The Bayer drug plus standard care also delayed tumor growth for an average of two months compared with 1.7 months for standard care alone.
"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, director of the Office of Hematology and Oncology Products in FDA's Center for Drug Evaluation and Research, said in a statement.
In August, the FDA approved Zaltrap, an advanced colon cancer treatment from Sanofi SA and Regeneron Pharmaceuticals.
Onyx Pharmaceuticals Inc is entitled to a 20 percent royalty payment on global net sales of Stivarga under a collaboration agreement with Bayer. The two companies already share the kidney and liver cancer drug Nexavar.
Porges, Bernstein's biotechnology analyst, called the Onyx royalty agreement, "a fairly attractive deal."
But he said initial sales expectations for Stivarga are relatively modest "because this is really a relatively small indication late in the disease."
Sales forecasts would rise considerably if Bayer were to later gain approval for the drug's use as an initial treatment for colon cancer.
Stivarga is a pill that works by blocking several enzymes that promote cancer growth.
The drug was reviewed under the FDA's priority review program that provides an expedited six-month review for drugs that offer major advances in treatment or that provide treatment when no adequate therapy exists. A decision had been expected by Oct. 27.
The Stivarga label will include a warning that severe and fatal liver toxicity occurred in some patients treated with the medicine during clinical studies, the FDA said.
In addition to Zaltrap, Stivarga will likely also compete with Roche Holding AG's multibillion-dollar cancer drug Avastin and Erbitux from Bristol-Myers Squibb Co and Eli Lilly and Co.
An estimated 143,460 Americans will be diagnosed with colorectal cancer, and 51,690 will die from the disease in 2012, according to the National Institutes of Health.
Bayer shares rose 1.3 percent to 68.40 euros in Germany. Onyx shares were up nearly 2 percent at $84.14. (Reporting by Bill Berkrot in New York; editing by Gerald E. McCormick, Matthew Lewis and Carol Bishopric)

Also on HuffPost:

"; var coords = [-5, -72]; // display fb-bubble FloatingPrompt.embed(this, html, undefined, 'top', {fp_intersects:1, timeout_remove:2000,ignore_arrow: true, width:236, add_xy:coords, class_name: 'clear-overlay'}); });

Source: http://www.huffingtonpost.com/2012/09/27/stivarga-advanced-colon-cancer-drug-fda_n_1919525.html

kevin love think like a man world peace world peace lakers colorectal cancer metta kashi