Biotech Values

[DewDiligence]

New Survey on Erbitux in First-Line Colorectal Cancer

Background: Results of the CRYSTAL study of chemo ± Erbitux in first-line colorectal cancer were mixed. The primary endpoint of PFS was statsig with HR=0.85 (p=0.048), but the secondary endpoint of overall survival missed being statsig with HR=0.93 (p=0.305).

In the subgroup with wild-type K-ras, PFS was statsig with HR=0.68 (p=0.017), but OS missed being statsig with HR=0.84 (p=0.217).


Q1: Which is the most likely FDA action on the sBLA
to expand the Erbitux label into the first-line setting?

a) Unconditional approval
b) Approval for wild-type K-ras only
c) Rejection


Q2: What market share (currently 4%) will
Erbitux eventually garner in first-line mCRC?

a) 0-4%
b) 5-9%
c) 10-19%
d) 20% or more


To vote, go to
http://www.investorshub.com/boards/board_surveymenu.asp?board_id=1418
and select survey #107.