Biotech Values

[walldiver]

Trials randomized 2:1, treatment:placebo. Probably around 145-150 patients on Provenge, plus approximately 75% of the placebo patients will have crossed over to receive salvage Provenge after progression. In the 9901 trial, the two-year survival data was 26.3 months for the Provenge arm, 23.9 months for the placebo arm crossovers, and 19.3 months for the placebo arm patients who opted not to cross over. Approx 75% of the 9901 patients opted to cross over.

Based on the final 36-month results, which showed 25.9 months for Provenge and 21.4 months for placebo for the 4.5-month survival benefit, I think it will turn out to be close to an 8-month benefit for Provenge versus the placebo arm patients who chose not to cross over.

What would be the harm of approving a therapeutic agent with an extremely mild toxicity profile that shows a substantially better survival advantage (with a p value probably less than 0.01) than a 6-month course of a toxic chemo?

As for previous approvals with small trial sizes, how about Gleevec?