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Biotech / Medical : Pharma News Only (pfe,mrk,wla, sgp, ahp, bmy, lly) -- Ignore unavailable to you. Want to Upgrade?

To: Anthony Wong who wrote (956)	10/24/1998 1:54:00 PM
From: Anthony Wong	Respond to of 1722

Pharmacia & Upjohn Wins FDA Nod for Wider Use of Cancer Drug Bloomberg News October 22, 1998, 10p.m. ET Washington, Oct. 22 (Bloomberg) -- Pharmacia & Upjohn Inc. said it won an approval from the U.S. Food and Drug Administration to make stronger claims about its cancer drug Camptosar. Pharmacia, which also makes the Rogaine treatment for baldness, won FDA clearance to say the drug, already approved for use by patients with advanced cancer of the rectum or colon, can actually stave off death in patients with metastatic or spreading cancer and in patients who have become resistant to their only other existing drug option. ''We can now demonstrate a survival benefit to oncologists, who in turn can have increased confidence that Camptosar is the standard of care,'' for their patients, said Karrie Cox, senior vice president of global business management for Pharmacia & Upjohn. While the drug has been available for use in colorectal cancer patients, this is proof for doctors that its benefits far outweigh the cost of side effects such as diarrhea. In terminally ill patients, that is the equation doctors must weigh. Pharmacia is already researching the use of the drug as a first option for cancer patients and is looking at its application to other cancers, such as lung and brain cancers. The current market for the drug is about 50,000 patients, according to the company. ''Camptosar is a major product in the oncology field and the cornerstone of our oncology franchise,'' Cox said. ''We anticipate that (this) approval of Camptosar will have a positive impact on sales.'' The drug initially passed FDA review through what is known as an accelerated approval, designed to get promising drugs to desperately ill patients after an abbreviated testing period. Before Camptosar, patients with colorectal cancer had few options, so the FDA cleared the drug based on data that showed it reduced tumor size, but left unanswered some questions about the drug's long-term benefits. The company returned with longer term data supporting the ''survival'' claim. A survival claim may increase the likelihood the sickest of cancer patients -- and their doctors -- would opt to use the drug and try yet another round of chemotherapy. Camptosar is made and sold in the U.S. and other countries by Pharmacia & Upjohn, the world's 18th biggest drugmaker, and by leading French drugmaker Rhone-Poulenc SA in Europe. Leading Killer Among cancers, only lung cancer kills more Americans than colorectal cancer, which kills about 55,000 people a year in the U.S. alone. Pharmacia's data offers hope to the large number of patients whose colon or rectal cancer is detected late and whose disease has spread. When it was initially approved by the agency in 1996, Camptosar was the first drug in 40 years, and only the second drug ever, designed to treat the prevalent cancer. Patients taking the drug were more likely to survive another year than were patients who received supportive care such as pain medication but no aggressive therapy after the first drug failed. Patients on Camptosar also fared significantly better in terms of pain, weight loss, and almost all other measures of quality of life. Metastatic colorectal cancer, or cancer where the disease has spread throughout the body, is more difficult to treat than the early form of the disease. About 95 percent of patients whose cancer is detected early survive at least five years, according to the American Cancer Society. Pharmacia & Upjohn has a number of other potential cancer drugs in development, including drugs to treat breast cancer, brain cancer and a form of anemia common in cancer patients. --Kristin Reed in Washington (202) 624-1858 through the New York