approval for colon cancer drug
Food and Drug Administration on Thursday approved a new drug for advanced colon cancer developed by Bayer AG, a month canada goose ahead of the agency expected action date for a decision.
The drug, to be sold under the brand name Stivarga, was canadagoosejacket-outlet approved to treat colon cancer that has progressed canada goose uk shop after prior treatment or that has spread to other parts of the body, the agency Canada Goose online said.
has clearly lit a fire under Canada Goose Jackets the FDA, canada goose uk outlet Sanford Bernstein analyst Canada Goose sale Geoffrey Porges said of the speedy approval. seeing a fairly consistent pattern of drugs for high unmet canada goose store needs diseases being approved on an expedited basis.
Bayer said Stivarga will be ready for distribution as soon as Friday and set a wholesale price for the drug of $9,350 for a 28 day cycle of treatment.
In pivotal clinical trials, Stivarga known chemically as regorafenib helped severely ill patients live on average 1.4 months longer than those who received standard treatment without the Bayer drug. Stivarga plus standard care also delayed tumor growth for an average of two months compared with 1.7 months for standard care alone. approval of regorafenib as a treatment for gastrointestinal stromal tumors.
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 cheap canada goose uk Products in canadian goose jacket FDA Center for Drug Evaluation and Research, said in a statement.
In August, the FDA approved Zaltrap, an advanced buy canada goose jacket cheap colon cancer treatment from Sanofi SA and Regeneron Pharmaceuticals.
Onyx Pharmaceuticals Canada Goose Outlet Inc is entitled to canada goose coats on sale a 20 percent royalty payment on global net sales of Stivarga under a settlement agreement with Bayer following a dispute over how closely related the medicine is to Nexavar, the Canada Goose Coats On Sale kidney and liver cancer drug that the companies co developed and share.
Bayer and Onyx will jointly promote Stivarga in Canada Goose Parka the United States.
Porges, uk canada goose outlet Bernstein canada goose black friday sale biotechnology analyst, canada goose coats called the Onyx royalty agreement, fairly attractive deal.
But he said initial sales canada goose factory sale expectations for Stivarga are relatively modest this is really a canada goose clearance relatively small indication late in the disease.
However, Morningstar analyst Damien Conover forecast sales of the canada goose clearance sale drug reaching $1 billion by 2020. Bayer declined to provide its own sales forecast for the medicine.
has very high expectations for Stivarga, Shannon Campbell, head of oncology for Bayer Healthcare, said in a telephone interview. certainly expect that Stivarga is going to play an important role once uk canada goose (patients) have gone through some of the more standard infusion based chemotherapies that are out there.
Stivarga is a pill that works by blocking buy canada goose jacket several enzymes that promote cancer growth.
The drug was reviewed under the canada goose outlet nyc FDA 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 October 27.
The Stivarga label will include a warning Canada Goose Online that severe and cheap Canada Goose 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 multibillion dollar cancer drug Avastin and Erbitux from Bristol Myers Squibb Co and canada goose uk black friday 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.
Reporting by Bill Berkrot in New York; editing by Gerald E. McCormick, Matthew Lewis and Carol Bishopric.