In Brief: Immunex' Leukine

Executive Summary

Immunex' Leukine: Supplemental PLAs for chemotherapy-induced neutropenia and use in acute myelogenous leukemia will be reviewed by FDA's Biological Response Modifiers Advisory Committee "in early April," Immunex announces March 13. FDA tentatively has set a meeting date for the committee of April 10-11. FDA requested more information on the clinical data submitted for the GM-CSF product sargramostim, the company says; "based on the questions received and discussions with the FDA to date, the company believes these questions and comments can be addressed without posing a significant delay in the review process"...