Do you believe Alimta has a more favorable toxicity
profile than docetaxel?
If the answer is yes, does the more favorable Alimta toxicity
profile with supporting efficacy data on tumor response and
PFS outweigh the uncertainty regarding loss of docetaxel
survival effect by using Alimta?
Given the potential confounding effects of cross-over,
and problems in estimating the control effect, is there a
convincing effect on survival to warrant regular approval?
Oncologic Drugs Advisory Committee
Questions to the Committee