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FDA APPROVAL OF COLORECTAL CANCER TREATMENT -
FIRST TO BE BASED ON SURVIVAL DATA

Patients with Metastatic Colorectal Cancer Treated with Camptosar® Live Longer

Bridgewater, NJ, October 22, 1998 ≠ For the first time ever, the U.S. Food and Drug Administration (FDA) today approved a colorectal cancer treatment based on its ability to increase survival. The treatment, Camptosar® Injection (irinotecan hydrochloride injection), developed by Pharmacia & Upjohn, is indicated for use in patients with metastatic colorectal cancer whose disease has recurred or spread following treatment with the current standard chemotherapy. It is the first treatment for colorectal cancer — the second leading cause of cancer mortality among all Americans — to be given full approval in more than 40 years. "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," said Richard Pazdur, M.D., Professor of Medicine, The University of Texas M.D. Anderson Cancer Center.

It is estimated that 80 to 90 million people are currently at risk for colorectal cancer because of age or other factors. This year alone, an estimated 131,000 Americans will be diagnosed with colorectal cancer, and 56,500 people will die of the disease.

"Stop Colon/Rectal Cancer Foundation applauds the FDA approval of the second only treatment for advanced colorectal cancer," stated Dr. Ernestine Hambrick, Founder. "We are encouraged to have another weapon in the armamentarium for use in the battle against advanced disease."

The FDA decision to grant full approval was based on the results of two adequate and well-controlled international Phase III clinical trials that demonstrate Camptosar (350 mg/m2 once every three weeks) significantly increases survival in patients with metastatic colorectal cancer who develop recurrent or progressive cancer despite first-line therapy with fluorouracil (5-FU). Survival was the primary efficacy measurement in these trials, and secondary measurements included the European Organization of Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire and measures of clinical benefit.

Significant Results

One randomized Phase III multicenter trial compared Camptosar and best supportive care with best supportive care alone in 279 patients with metastatic colorectal cancer who had previously experienced failure of standard 5-FU therapy. On average, patients receiving Camptosar lived significantly longer, 9.2 months compared with 6.5 months for patients receiving best supportive care alone, representing a median survival increase of 41 percent.

The study is the first to show that active treatment with Camptosar improves certain aspects of quality of life, as measured by the EORTC Quality of Life instrument. Patients receiving Camptosar noted significant improvements in seven of fifteen subscales including global health status, physical and role functioning, and symptoms of fatigue, appetite loss, pain and constipation. Patients receiving Camptosar experienced more diarrhea than those receiving best supportive care.

The second Phase III multicenter trial compared Camptosar to 5-FU in 267 patients with metastatic colorectal cancer whose disease had recurred or progressed despite standard first-line therapy with 5-FU. On average, survival of patients treated with Camptosar was 10.8 months compared with 8.5 months for patients receiving 5-FU, representing a median survival increase of 27 percent. The difference in survival was statistically significant. The results of the EORTC Quality of Life Questionnaire did not indicate a statistically significant difference between Camptosar and 5-FU.

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 the two Phase III trials, the most clinically significant adverse events were diarrhea (84 percent), alopecia (72 percent), nausea (70 percent), vomiting (62 percent), cholinergic symptoms (47 percent), and neutropenia (30 percent). Eight percent of patients treated with Camptosar discontinued treatment due to adverse events.

Two dosage schedules for Camptosar have been approved by the FDA — 125 mg/m2 administered once weekly for four weeks, followed by a 2-week rest period, and now a new regimen — 300-350 mg/m2 every three weeks. The availability of two Camptosar regimens provides patients and physicians greater flexibility in the therapy of colorectal cancer.

"Prior to the approval of Camptosar, the treatment options we could offer patients with metastatic colorectal cancer were extremely limited. With the full approval of Camptosar, an entirely new standard of care in second-line therapy of this disease has been established," said Dr. Pazdur. "In a traditionally difficult-to-treat disease like colorectal cancer, this approval can benefit many of the thousands of patients with metastatic colorectal cancer."

Camptosar received an accelerated approval in June 1996 to treat metastatic cancer of the colon or rectum that has recurred or progressed after standard therapy with the anticancer agent 5-FU. Because data from Phase III clinical trails were not available, marketing authorization was granted under regulations designed to accelerate approval of new drugs for serious or life-threatening illnesses.

Camptosar® is a registered trademark of Pharmacia & Upjohn. Pharmacia & Upjohn is a global, research-driven pharmaceutical and health care company whose products, services and employees demonstrate its commitment to improving quality of life for people worldwide.

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