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| |  FDA Committee Recommends Camptosar (Irinotecan) For Colorectal Cancer WASHINGTON, DC -- March 17, 2000 -- The U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) unanimously recommended approval of Camptosar (R) (CAMP-to-sar) (irinotecan hydrochloride injection), as first-line therapy for the treatment of patients with metastatic (widespread) colorectal cancer in conjunction with fluorouracil [5FU] and leucovorin. Camptosar is being considered for FDA approval based on survival data from two prospective, independent studies presented to the committee that demonstrate its potential in extending patients' lives when used as a first-line treatment for colorectal cancer. ODAC's unanimous recommendation for FDA approval was made after the company presented data from two well-controlled international (one North American, one European) Phase III clinical trials. Study results suggest significant improvements in objective tumor response rates, time to tumor progression, and prolongation of survival for the regimen of Camptosar and 5FU/leucovorin compared with 5FU/leucovorin alone. "It is really exciting that the North American and European trials independently suggest the same basic benefits; the addition of irinotecan to 5FU/leucovorin results in a generally well-tolerated regimen with superior anti-tumor activity and prolonged patient survival," says Leonard Saltz, M.D., Principal Investigator of the North American Phase III trial and Associate Attending Physician at Memorial Sloan Kettering Cancer Center. The trials also utilized the well-validated European Organization of Research and Cancer (EORTC) Quality of Life Questionnaire. Throughout the trial, indicators such as general health status, role functioning and symptoms such as pain were measured. Data suggest that the addition of Camptosar to 5FU and leucovorin did not compromise prespecified quality of life indicators for patients in either study. "We are pleased that an additional treatment option is available for the treatment of colorectal cancer," said Nancy Roach, Board of Directors, Colon Cancer Alliance. "Each new drug approval gives survivors renewed hope for longer and better quality of life." In the North American Phase III trial, adverse events occurring more commonly in patients on Camptosar and 5FU/leucovorin than 5FU/leucovorin alone were diarrhea, nausea and vomiting. However, there was less mucositis and less severe neutropenia in the regimen containing Camptosar . Camptosar is associated with both early (during or shortly after infusion) and late (more than 24 hours after infusion) forms of diarrhea, that may be severe. Early diarrhea may be accompanied by symptoms such as sweating, flushing and abdominal cramping, and may be treated with atropine. Late diarrhea can be prolonged, life threatening, and should be treated promptly with loperamide. In addition to its current colorectal cancer indication, Camptosar is being studied as an adjuvant treatment option (with 5FU/leucovorin) for earlier stage colorectal cancer through an NCI-supported inter-group study. Camptosar is also in clinical development for the treatment of other malignancies such as lung and pancreatic cancer. Pharmacia and Upjohn recently announced the initiation of a comprehensive clinical trial program studying Camptosar in combination with semoxind (SU5416), an investigational anti-angiogenesis agent currently being researched at Sugen, Inc. Camptosar received full approval from the FDA in 1998 as a second-line treatment for metastatic colorectal cancer. Pharmacia & Upjohn expects to launch Camptosar as a first-line treatment for metastatic colorectal cancer in May 2000. Camptosar is marketed in Canada, New Zealand, Australia and Latin America. Pharmacia & Upjohn has a long history of bringing effective cancer treatments to market. The company introduced anthracyclines, the cornerstone of chemotherapy used for solid tumors, in the 1960s. The company's current oncology portfolio includes Ellence(TM), the number two selling cytotoxic agent in Europe today and number nine worldwide, Idamycin and Zinecard. Compounds in the development pipeline include TPO for thrombocytopenia and products for a broad range of tumor types, including those occurring in the breast, lung, brain, esophagus and pancreas. Related links: Camptosar, Leucovorin.
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