Irinotecan—A Case Study for the Transition from Accelerated Approval to Traditional Approval

Abstract

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.