Dew,
The more knowledgeable posters on the GNVC Yahoo board are pointing to Tarceva's results as indicating that TNFerade results are comparable in a very difficult to treat cancer. Can you help me here? What is wrong with their reasoning?
See below what Tarceva got and they got FDA approval.
Tarceva® (erlotinib) Tablets, NDA 21-743, S003: Supplemental NDA
Briefing Document – 13 September 2005 ODAC Meeting
Page 7 09 AUG 2005
The primary analysis was for overall survival in the intent-to-treat (ITT) population. In
this ITT population (N = 569, 521 patients in the 100 mg cohort and 48 patients in the
150 mg cohort), Tarceva plus gemcitabine demonstrated a statistically significant
improvement in overall survival compared with gemcitabine alone (hazard ratio
[HR] = 0.79, 95% confidence interval [CI] 0.66 to 0.95, p = 0. 011), indicating Tarceva
plus gemcitabine yielded a 27% increase in survival and reduced the risk of death by 21%
compared with treatment with gemcitabine alone (see Figure 1-1). The estimated 1-year
survival rate in the ITT population for patients treated with a combination of Tarceva plus
gemcitabine was 24% compared with 17% for patients treated with gemcitabine alone. A
subsequent FDA-requested analysis that updated survival data as of 18 months after the
original cutoff date also demonstrated statistically significant improvement in overall
survival: HR = 0.81, 95% CI 0.68 to 0.96, p = 0.016.
Figure 1-1: Overall Survival Primary Stratified Analysis – All Randomized Patients
* Adjusted for PS and extent of disease at randomization
HR = 0.79* (95% CI, 0.66 - 0.95)
p = 0.011
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