Biotech Values

[iwfal]

DNDN -

So.... where exactly do you see only a "marginal" effect?

I suspect he is making reference to the fact that 50% or more of drugs approved in onc with survival data have survival HR<0.75. (My guesstimate based upon previous scans through FDA approvals - but if you want to confirm try a google search on fda approvals for survival in cancer). And, in fact, in the recent FDA discussion of the Tarceva data (where the FDA overruled the ODAC) they made reference to wanting to see around 0.8 or better. Thus the IMPACT HR is on the high side.

Obviously there are other considerations as well:

a) low tox profile (e.g. some drugs, like Alimta, do quite well even with marginal efficacy because of low tox.)

b) number of indications (are there any blockbusters in onc with only one indication - my guess is that there are, but virtually all will be with survival HRs substantially better than 0.75.)


PS A technical consideration is that Prostate Cancer trials inevitably suffers from a disadvantage over trials in other cancers with regard to survival HR - Prostate Cancer has a long median survival and is in the elderly and thus the treatment HR is washed out by the high die-of-old-age rate. My guesstimate is that cancer specific mortality for Provenge is actually in the middle of the pack, or somewhat better, when compared to other onc drugs using "cancer specific mortality" (which is tricky - since a lot of cancer mortality is not directly attributable to the cancer (see the below cite - which is one of many I have seen)).


http://www.ncbi.nlm.nih.gov/pubmed/16489536