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.
