Biotech Values

[jq1234]

Why does it matter if the control arm was another drug or not? If it's a properly run controlled trial that doesn't deprive patients of suitable treatment (presumably the rida control arm is BSC), why should the agency think less of it? If it's the suitable trial for the stage of disease, then...? Tarceva did just fine getting on the market for lung cancer based on a trial versus BSC.

We are talking about comparing trial, and data relevance across setting and indication. You have to be careful what you compare to. You have to put data in correct context. The tendency is to compare to any cancer in any setting, which ususally draws wrong conclusion.

Comparing Rida in maintenance setting for sarcoma with Tarceva in 1st line pancreatic cancer in combination with gemzar against gemzar is comparing apple to orange. Tarceva data in pancreatic cancer might not have met expectation at that time, but there was little argument against approval, because 1. first line vs SOC with both stat significant PFS and OS; 2. pancreatic cancer is much much more agressive cancer, small improvement might not be much in absolute term, but in relative term of the disease it is different. If rida were in 1st line setting against SOC with stat significant PFS and OS, no matter how small, I am not going to make same argument here.

My point is Tarceva in maintenance setting in NSCLC is the appropriate comparison here. ODAC argued against approval even though stat significant PFS and OS, 2 weeks and 1 month respectively. At this point, there is no gurantee rida's 3-week PFS advantage will translate into OS advantage.

Tarceva in 2nd/3rd line NSCLC vs placebo data were impressive, no argument there.