The United States Food and Drug Administration (FDA) has adopted its accelerated approval regulation as a means of expediting the approval of agents to treat serious or life-threatening illnesses. As of February 15, 2000, 11 oncology products to be used either in the treatment of cancer or in the amelioration of side effects caused by antitumor agents have received accelerated approval.
Camptosar® Injection (irinotecan hydrochloride injection) is an antineoplastic agent that received an accelerated approval on June 14, 1996 for the second-line treatment of metastatic colorectal cancer. Two meetings were held with FDA to discuss the use of data from two Phase III studies conducted by Rhone-Poulenc Rorer to support traditional approval. A Supplemental NDA (sNDA) was then submitted on April 28, 1998 and subsequently approved on October 22, 1998. This case study illustrates the flexibility on the part of FDA to allow data not initially proposed to support traditional approval.
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Federal Register. Food and Drug Administration. Department of Health and Human Services. 1992; 57: 58942–58960.
Code of Federal Regulations. Tide 21. Part 314.
Code of Federal Regulations. Title 21. Part 601.
Cunningham D, Pyrhönen S, James, RD. et al. Randomised trial of irinotecan plus supportive care versus supportive care alone after fluorouracil failure for patients with metastatic colorectal cancer. Lancet. 1999;352: 1413–1418.
Rougier P, Van Cutsem E. Bajetta E, et al. Randomised trial of irinotecan versus fluorouracil hy continuous infusion after fluorouracil failure for patients with metastatic colorectal cancer. Lancet. 1999;352: 1407–1412.
Presented at the DIA 35th Annual Meeting, June 27–July 1, 1999, Baltimore, Maryland.
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Mannix, D.G. Irinotecan—A Case Study for the Transition from Accelerated Approval to Traditional Approval. Ther Innov Regul Sci 34, 737–740 (2000) doi:10.1177/009286150003400309
- Food and Drug Administration
- Accelerated approval
- Surrogate marker
- Colorectal cancer