BioCentury
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ImClone falls on BLA setback

December 31, 2001 8:00 AM UTC

IMCL was off $8.79 (16%) to $46.46 on Monday. On Friday after market close, the company said the FDA would not accept for filing its BLA for Erbitux ( IMC-C225) anti-EGFr antibody to treat irinotecan-refractory colorectal cancer. According to the company, the filing did not include documents to support conclusions on whether patients were refractory to irinotecan and conclusions on patients' response rates.

IMCL President and CEO Samuel Waksal said in a conference call that FDA's primary issue is the "clarification and inclusion of additional data from the company's pivotal Phase II study." In that trial, investigators determined whether patients were refractory to irinotecan and patients' response rates. An independent committee of radiologists (IRAC) also reviewed these 2 sets of data. Waksal said there was "high concordance between investigators and IRAC" in their respective assessments of the refractory and response rate data sets. However, Waksal told BioCentury that "IRAC didn't document how they came to their conclusions, and we didn't emphasize the need for this paper trail." Thus, said Waksal, "we feel we did not fail to meet our clinical endpoints; however, the company did fail to provide a proper train of documentation which would allow the FDA to accept this filing." ...