BioCentury
ARTICLE | Regulation

Getting the benefit of the doubt

September 17, 2001 7:00 AM UTC

Neither Idec Pharmaceuticals Corp.'s Zevalin ibritumomab for non-Hodgkin's lymphoma nor Matrix Pharmaceutical Inc.'s IntraDose for head and neck cancer showed statistically significant improvements in patient benefit in Phase III trials, while both had positive tumor response data. Yet the FDA's Oncologic Drugs Advisory Committee last week recommended approval of Zevalin and recommended against approval of IntraDose.

The key was the panel's belief that the tumor responses in IDPH's case ultimately would confer clinical benefit, and their skepticism about whether tumor responses in MATX's trials would do so...