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

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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.

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References

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    Code of Federal Regulations. Tide 21. Part 314.

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Author information

Correspondence to Dr. Daniel G. Mannix PhD.

Additional information

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

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Key Words

  • Irinotecan
  • Food and Drug Administration
  • Accelerated approval
  • Surrogate marker
  • Colorectal cancer