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JAMA. 2002;288:1225.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

The FDA has given accelerated approval to oxaliplatin (Eloxatin, Sanofi-Synthelabo Inc, New York), a new antineoplastic agent with antitumor activity that differs from cisplatin and carboplatin. The drug is indicated for use as an injection in combination with infusional 5-fluorouracil and leucovorin (5-FU/LV) for the treatment of patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following first-line therapy with bolus 5-FU/LV plus irinotecan.

Approval is based on results of an ongoing multicenter, randomized, controlled study in the United States and Canada comparing safety and effectiveness of oxaliplatin in combination with infusional 5-FU/LV with that of infusional 5-FU/LV alone and with oxaliplatin alone. The interim analysis of response rate and time to radiograpic progression included 463 patients. Data continues to be collected on overall survival. Tumor response was assessed every 6 weeks. Confirmed objective responses were based on two tumor assessments separated by at . . . [Full Text of this Article]