The FDA's Oncology Drugs Advisory Committee has made aconditional recommendation for market approval of Quadra LogicTechnologies Inc.'s Photofrin, a light-activated drug, for use as apalliative treatment of esophageal cancer.Ken Gailbraith, Quadra Logic's vice president of finance and chieffinancial officer, said the committee's recommendation for approvalwas conditional on the company and the FDA working out finalindications and labeling for the photosensitive drug.Quadra Logic is seeking approval of Photofrin for treatment of totally-and partially-obstructing cancers of the esophagus."The advisory committee members had some concerns they wanted usto address," Gailbraith told BioWorld. "They wanted us to identifymore specifically the sub-population of patients for partially-obstructedcancer of the esophagus and there were some safety issues. Theywanted to make sure adverse effects that showed up in clinical trialswere identified on the label."Gailbraith called the FDA committee's recommendation positive andsaid Quadra Logic expects to meet soon with the FDA to resolve theconcerns. If approved, Photofrin would be used to treat advancedesophageal cancer, for which the five-year survival rate is less than 10percent.Quadra Logic last week received approval in Japan to market the drugfor superficial esophageal cancer, early-stage lung cancer, superficialand early-stage gastric cancers, early-stage cervical cancer and cervicaldysplasia.The drug also is approved in Canada for superficial bladder cancer andin The Netherlands for early- and late-stage lung and esophagealcancers.Photofrin is administered by injection and is carried by lipoproteins tocancerous tumors, which have three to four times the concentration oflipoproteins than normal tissue. When the drug is activated withphotodynamic therapy, it produces toxic oxygen compounds that aredesigned to destroy the tumor. _ Charles Craig
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