FDA GIVES OK FOR AMGEN'S VECTIBIX DRUG COLORECTAL CANCER-FIGHTER SET FOR USE BEGINNING IN OCTOBER.Byline: BRENT HOPKINS Staff Writer THOUSAND OAKS Thousand Oaks, residential city (1990 pop. 104,352), Ventura co., S Calif., in a farm area; inc. 1964. Avocados, citrus, vegetables, strawberries, and nursery products are grown. -- Amgen Inc. won a significant victory Wednesday as the U.S. Food and Drug Administration approved its colorectal cancer colorectal cancer Malignant tumour of the large intestine (colon) or rectum. Risk factors include age (after age 50), family history of colorectal cancer, chronic inflammatory bowel diseases, benign polyps, physical inactivity, and a diet high in fat. fighter Vectibix. The medication, known generically as panitumumab, proved in clinical trials to prevent progression of tumors that have spread to other parts of the body in patients for whom chemotherapy failed. The company expects to begin marketing the treatment in October and will price it 20 percent below competitive therapies. Analyst reports project Vectibix could eventually bring in more than $1 billion in annual revenue, and a doctor involved in the past five years of clinical trials said it presents a significant treatment option for one of the most deadly forms of cancer. ``This is our first foray into Verb 1. foray into - enter someone else's territory and take spoils; "The pirates raided the coastal villages regularly" raid encroach upon, intrude on, obtrude upon, invade - to intrude upon, infringe, encroach on, violate; "This new colleague invades my the tumor-shrinking business,'' said Cynthia Schwalm, a former oncology nurse oncology nurse Nursing A nurse specialized in treating and caring for people with cancer Salary $53K + 2% bonus. See Oncology. who now serves as Amgen's vice president and general manager of oncology. ``It's the first in a whole line of products that will make us the most comprehensive cancer company in the world.'' According to the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. , doctors will diagnose 150,000 new cases of colon cancer colon cancer, cancer of any part of the colon (often called the large intestine). Colon cancer is the second most common cancer diagnosed in the United States. this year and the disease will claim 55,000 lives. The agency approved Vectibix after trials on 463 patients whose cancer had metastasized and had not responded to other treatments. In the trials, patients on Vectibix had a mean time of 96 days before their diseases progressed or they died, compared with 60 days for patients on alternative care. Eight percent of the Vectibix patients' tumors shrunk, some as much as 50 percent. ``There was a major improvement in keeping cancer from growing,'' said Dr. J. Randolph Hecht, a clinical professor of medicine and researcher for the UCLA UCLA University of California at Los Angeles UCLA University Center for Learning Assistance (Illinois State University) UCLA University of Carrollton, TX and Lower Addison, TX Jonsson Cancer Center. ``The percentage of people who got worse was much higher in the people who didn't get the Vectibix.'' This represents a significant business opportunity for Amgen, according to Sanford Bernstein analyst Geoff Porges. Between the current application and possible future expansions of the line, ``they could probably get to $700 million to $800 million a year,'' he told the Reuters wire service. Other reports put the potential annual income as high as $2 billion. brent.hopkins(at)dailynews.com (818) 713-3738 |
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