Campto(R) (Irinotecan/CPT-11) Now Available in France for Treatment of Colorectal Cancer

France is the first country outside Japan to make Campto available to patients, marking a significant breakthrough in the treatment of colorectal cancer. Developed and brought to market by Rhone-Poulenc Rorer Inc. in near record time, Campto has demonstrated significant anti-tumor activity in patients with advanced colorectal cancer that has failed standard chemotherapy. With 5-fluorouracil (5-FU) being the only effective agent in the treatment of this disease for 40 years, Campto offers a new hope for patients.

Key Takeaways:

  • Campto, the first new therapeutic innovation for colorectal cancer in nearly 40 years, has significant anti-tumor activity in patients with advanced colorectal cancer that has failed standard chemotherapy.
  • The drug has been made available in France, the first country outside Japan to market Campto, after being developed and brought to market by Rhone-Poulenc Rorer Inc. in near record time.
  • Campto was licensed by RPR from Yakult Honsha Co. Ltd. in Japan and is being developed throughout Europe by RPR.
  • A large French clinical trial showed Campto has a clinically significant response rate of 20% in patients with advanced colorectal cancer.
  • In the pivotal Phase II clinical trial, 28 patients out of 156 evaluable patients experienced a partial response to treatment with Campto.
  • The median duration of response was 9.1 months, and more than one third of patients were free from progression for six months.
  • Campto acts as a potent inhibitor of topoisomerase I, an enzyme essential for cell division, and is being investigated in combination with 5-FU or with other promising agents in development.
  • Side effects of Campto have been controlled through concomitant medications such as loperamide and antibiotics.
  • Advanced clinical trials have begun or are being planned in most European countries, with RPR committed to aggressively supporting and conducting clinical trials to bring the drug to patients as quickly as possible.

Statistics:

  • Over 140,000 people are diagnosed with colorectal cancer each year in Europe (26,000 in France).
  • About 50% of patients are cured by surgery, while the other half become metastatic and require treatment with an anti-cancer drug.
  • For 40 years, 5-FU has been the only effective agent in the treatment of advanced colorectal cancer, with a clinical response rate of 10-25% in most cases.
  • In the pivotal Phase II clinical trial, 20% of patients experienced a clinically significant response to treatment with Campto.
  • The median duration of response was 9.1 months, with a range of 1.6 to 17 months.

Sources:

  • Rhone-Poulenc Rorer Inc. press release, September 14, 1995
  • Rhone-Poulenc Rorer Inc. website (http://NoonanRusso.com)
  • PR Newswire's Company News On-Call fax service and on PRN's Web site (http://www.prnewswire.com)
  • Yakult Honsha Co. Ltd. (license agreement)