Rhone-Poulenc Rorer has submitted a license application to the French regulatory authorities for its anticancer drug irinotecan (also known as CPT-11). This is the first submission made by R-PR for the product, although it is already available in Japan (through originating companies Daiichi and Yakult Honsha as Topotecin and Campto, respectively).
R-PR is seeking approval to market irinotecan for patients with colorectal cancer that has progressed despite treatment with 5-fluorouracil, the current standard treatment for the disease. The company said that it would be submitting further applications in other European countries following the submission in France.
Irinotecan is the first of a new class of anticancer agents called topoisomerase I inhibitors. Data from recent clinical trials with the drug suggest that it can achieve response rates of around 20% in previously-treated colorectal cancer patients (Marketletter December 19, 1994).
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