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| |  FDA Advisory Committee Recommends Camptosar For Colorectal Cancer BRIDGEWATER, NJ -- Sept. 3, 1998 -- The United States Food and Drug Administration’s oncologic drugs advisory committee today recommended full approval of Pharmacia & Upjohn’s Camptosar(R) Injection (irinotecan hydrochloride injection), for the treatment of patients with metastatic colorectal cancer after failure of previous chemotherapy (5-FU [fluorouracil]). Camptosar is being considered for approval based on data that shows Camptosar increases survival of patients with metastatic colorectal cancer whose disease has recurred or progressed following 5-FU based therapy. It is the first treatment for metastatic colorectal cancer to be recommended for full approval in more than 40 years. The second leading cancer killer of all Americans after lung cancer, colorectal cancer is cancer involving the lining of the large intestine or the rectum. It is estimated that 80 to 90 million people are 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. In the U.S., 56,500 people will die of the disease. The committee’s unanimous acknowledgement of Camptosar's survival benefit led to the recommendation for full approval. Two adequate and well-controlled international Phase III clinical trials that showed irinotecan increases survival of patients with metastatic colorectal cancer after failure of 5-FU. Survival was the primary efficacy measurement in these trials, and secondary measurements included quality of life (measured by physical functioning and symptoms like pain and fatigue) and clinical benefit. One randomised Phase III study compared irinotecan (350 mg/m-squared once every three weeks) and best supportive care (pain and symptom relief) with best supportive care alone in 279 patients with metastatic colorectal cancer whose cancer had recurred or progressed despite previous standard first-line therapy with 5-FU. The study demonstrated that at one year, 36.2 percent of patients treated with irinotecan and best supportive care were alive compared to 13.8 percent receiving only best supportive care. Thus, the likelihood of being alive at one year was 2.6 times higher with irinotecan treatment. On average, patients receiving irinotecan lived 9.2 months compared with 6.5 months for patients receiving best supportive care alone. "Colorectal cancer is the second deadliest cancer in this country -- 56,000 Americans are expected to die of this disease this year alone," said Richard Pazdur, M.D., professor of medicine, The University of Texas M.D. Anderson Cancer Center. "Colorectal cancer has a huge impact on society, yet for the last 40 years we've had limited options for treating the disease beyond surgery." A second randomised Phase III multicentre trial in patients with metastatic colorectal cancer who failed previous 5-FU treatment compared irinotecan with 5-FU as second-line therapy, the current standard of care. In this trial, 44.8 percent of patients treated with irinotecan were alive at one year compared with 32.4 percent of patients treated with 5-FU, representing a 40 percent increase in survival in favour of irinotecan. On average, survival of patients treated with irinotecan was 10.8 months compared with 8.5 months for patients receiving 5-FU. The difference in survival was statistically significant. 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, adverse events occurring more commonly in patients on Camptosar than best supportive care or 5-FU based therapy were diarrhea, nausea, vomiting and neutropenia. In these studies, 60 percent of patients receiving Camptosar were hospitalised at least once due to adverse events, compared with 63 percent receiving best supportive care alone and 39 percent receiving 5-FU. 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 5-FU. Because data from Phase III clinical trials were not available, marketing authorisation was granted under regulations designed to accelerate approval of new drugs for serious or life-threatening illnesses. The accelerated approval was based on three open-label Phase II clinical trials that showed an overall confirmed tumour response rate of 15 percent with Camptosar when given at a starting dose of 125 mg/m-squared in a weekly dosage schedule. The Phase III trials on which the current ODAC recommendation is based were initiated to confirm the anti-tumour effect of irinotecan on overall survival. These trials utilised a once-every-three-week dosing schedule (350 mg/ m-squared). ODAC recommended that both regimens now be available for use in patients. Related Links: Camptosar, Pharmacia & Upjohn
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