[MOL] FDA approves camptosar in combo therapy for metastatic colorectal [02280] Medicine On Line

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[MOL] FDA approves camptosar in combo therapy for metastatic colorectal cancer....

FDA Approves Camptosar (Irinotecan Hydrochloride) In Combo Therapy For Metastatic Colorectal Cancer

PEAPACK, NJ -- April 24, 2000 -- Pharmacia Corporation announced that the U.S. Food and Drug Administration (FDA) approved Camptosar(R) (irinotecan hydrochloride injection), as first-line therapy for the treatment of patients with metastatic colorectal cancer (advanced cancer that has spread beyond the colon or rectum) in combination with 5-fluorouracil/leucovorin (5-FU/LV).

The FDA approval is based on data from two prospective Phase III studies which demonstrated the potential of Camptosar to prolong patients' lives when used in combination with 5-FU/LV as a first-line treatment for metastatic colorectal cancer compared with 5-FU/LV alone. These studies, conducted primarily in North America and Europe, demonstrated significantly prolonged median survival, and significantly longer time to tumor progression for the regimen of Camptosar and 5FU/LV compared with 5FU/LV alone.

"The North American and European trials independently suggest the same basic benefits; the addition of irinotecan to 5FU/leucovorin results in a regimen with superior anti-tumor activity and prolonged patient survival," said Leonard Saltz, M.D., Principal Investigator of the North American Phase III trial and Associate Attending Physician at Memorial Sloan Kettering Cancer Center. "The FDA's Oncologic Drug Advisory Committee reviewed these trial results and the consensus was that the combination regimen containing irinotecan may represent a new standard against which future therapies should be compared."

Camptosar is associated with myelosuppression and 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.

Camptosar is being studied as an adjuvant treatment option (with 5FU/LV) 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 Corporation recently announced the initiation of a comprehensive clinical trial program studying Camptosar in combination with SU5416, an investigational anti-angiogenesis agent currently being researched at Sugen, Inc.

Camptosar was introduced in the U.S. in 1996 and received full FDA approval in 1998 as a second-line treatment for metastatic colorectal cancer. Camptosar also is marketed in Canada, New Zealand, Australia and Latin America.

The Company announced the termination of two projects in its research and development portfolio: SU-101 for the treatment of glioblastoma, a form of brain cancer, and pediatric studies of leridistim for treating complications of chemotherapy. A trial of leridistim in adult patients is ongoing and will continue to completion.

Pharmacia Corporation is a leading global pharmaceutical company created through the merger of Pharmacia & Upjohn and Monsanto Company with its G.D. Searle & Co. unit. Pharmacia has a broad product portfolio, a robust pipeline of new drugs, and an annual investment of more than $2 billion in pharmaceutical research and development. In its Monsanto subsidiary, Pharmacia has one of the world's leading fully integrated agricultural businesses.