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New Colon Cancer Drug Wins FDA's Approval

October 23, 1998| From Reuters

WASHINGTON — The Food and Drug Administration approved Pharmacia & Upjohn Inc.'s drug Camptosar on Thursday, a treatment that could help people with colon cancer live longer.

It was the first time in more than 40 years that the FDA gave full approval to a treatment for colon cancer, the second-most deadly form of cancer in the United States. It kills more than 56,000 Americans each year.

In a statement announcing the FDA approval, the company said Camptosar Injection was used for patients with metastatic colorectal cancer whose disease has recurred or spread after chemotherapy.

An FDA advisory panel on Sept. 3 had recommended full approval of the drug after reviewing two new European studies that showed that patients taking Camptosar lived significantly longer than those getting pain and symptom care or the standard therapy, 5-FU.

"The full approval of Camptosar can benefit many of the thousands of patients with metastatic colorectal cancer. We now can help some patients live longer, which is something we could not say with certainty until now," Richard Padzur, professor of medicine at the University of Texas M.D. Anderson Cancer Center in Houston, said in a statement.

New York Yankees baseball player Darryl Strawberry was diagnosed with colon cancer this month, calling attention to that form of cancer. He joins an estimated 131,000 Americans who are diagnosed with the disease each year.

Camptosar is a type of drug called a topoisomerase I inhibitor. It blocks an enzyme essential to cancer cell division and blocks tumor growth by that action. It is a semi-synthetic derivative of camptothecin, an extract of the Chinese Campthotheca acuminata tree.

In one study, patients lived an average 9.2 months, compared with only 6.2 months for palliative care. In the second trial, patients survived an average 10.2 months, compared with 8.4 for 5-FU. The FDA said the difference is significant.

"Prior to the approval of Camptosar, the treatment options we could offer patients with metastatic colorectal cancer were extremely limited," Padzur said, predicting thousands of patients will benefit from access to the drug.

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