SILVER SPRING, MD, Jun 08, 1999 (Reuters Health) - Advisers to the US Food and Drug Administration (FDA) on Monday urged approval of Pharmacia & Upjohn's epirubicin hydrochloride (Ellence) to treat locally advanced, but not metastatic, breast cancer. The Oncologic Drugs Advisory Committee voted unanimously to back epirubicin, an anthracycline, for adjuvant treatment of node-positive breast cancer following surgical resection.But it voted 6-3 against approval as a first-line treatment for metastatic disease. Overall, epirubicin-treated patients with metastatic disease had slightly longer survival, but both they and early-stage patients had a higher risk of congestive heart failure and leukemia. Although some patient advocates at the meeting argued for approval, others said they were not impressed with epirubicin."I see it has some survival benefit, but with significant toxic effects, so I don't see what's so exciting to the patient," said Susan Zook-Fischler, the panel's patient representative. Ann Fonfa of The Annie Appleseed Project in New York said, "I don't see any significant change in survival, and as a cancer patient, long term survival is what I care about."Fonfa chided the panel for not demanding a longer survival benefit for proof of efficacy."You're spending millions of dollars and you're not getting anything that's any better for cancer patients.Please, please aim higher, I beg you," she said. Epirubicin has been approved in 80 countries.Upjohn first applied for FDA approval in 1984, but was subsequently turned down because it did not have sufficient data, said the agency.After Upjohn merged with Pharmacia, the company reapplied in December 1998, using new data. Remember we are NOT Doctors and have NO medical training. This site is like an Encylopedia - there are many pages, many links on many topics. Support our work with any size DONATION - see left side of any page - for how to donate. You can help raise awareness of CAM.