To: Machaon who wrote (20019 ) 5/4/1998 2:24:00 PM From: Peter Singleton Respond to of 32384
Folks, sorry to interrupt the incessant bickering with a comment about biotech ... : ) Here's a little more information on Xeloda, Roche's just-approved product for metastatic breast cancer. From the below Reuters article, it's effectively an orally-available 5-FU, re-engineered to reduce side effects. Hence the efficacy, and the side effect profile. The big news here is that the FDA's response to this drug, which is really not that remarkable, confirms what people like Henry have been saying about the new environment for cancer drugs with the FDA. Very promising for LGND. Peter U.S. FDA approves last-ditch breast cancer drug WASHINGTON, April 30 (Reuters) - The U.S. Food and Drug Administration (FDA) approved a last-ditch drug for breast cancer on Thursday aimed at women whose illness is not being helped by other drugs. The FDA said it gave drugmaker Hoffmann-La Roche <ROCZg.S> accelerated approval for Xeloda, a new oral drug designed for patients whose breast cancer is not responding to other drugs. "Xeloda is a significant advance in the treatment of metastatic (spreading) breast cancer. At last, patients can take an effective pill, in their homes, to treat their cancer," said Dr. Linda Vahdat, director of the Autologous Transplant Program for Breast Cancer at Columbia-Presbyterian Medical Center in New York, said in a statement released by Roche. Xeloda, known generically as capecitabine, will be used in breast cancer patients who have not responded to Bristol-Myers Squibb's Taxol (paclitaxel) or chemotherapy such as 5-fluorouracil (5-FU). Xeloda is chemically related to 5-FU, but was designed to minimize side effects and is more convenient as it is given orally. In one trial, Xeloda was shown to reduce tumor size by more than 50 percent in one out of four patients with hard-to-treat tumors, the company said. About 120,000 women in the United States have metastatic breast cancer -- the kind that has spread in the body. "Women need to make informed decisions about their anti-cancer therapies, and consider both the efficacy and side effect profile of available treatments," Kristina Pavlou, Director of Patient Education for the Y-ME National Breast Cancer Organization, said in the statement. "Xeloda offers metastatic breast cancer patients a safe and effective treatment option, even after other therapies have failed." The company says Xeloda has fewer side effects than other cancer drugs. "Patients often associate chemotherapy with hair loss and bone marrow suppression, which can have a serious impact on a person's quality of life," Dr. Thomas Griffin, medical director of oncology at Roche, said. "We anticipate that Xeloda will help redefine chemotherapy." The most frequently reported side effects included diarrhea, nausea, vomiting, sores in the mouth and throat, and fatigue. But it can also cause severe diarrhea in patients over the age of 80 and could hurt the fetus of a pregnant woman. The FDA said that, as a condition of approval, it was requiring Roche to do more clinical tests on the drug. 23:01 05-01-98