Biotech Values

[AlpineBV_Miller]

Man, I don't know but my guess is they are larger than chemo. About 13% of patients die from the drug or have to have surgical intervention. Some other percentage on that path are resuced by hospitalization and intensive steroid therapy. Patients can be sailing along fine then weeks to moths after last therapy have their GI tract go south unexpectedly, which means any decent doctor will schedule regular follow-ups for months after final dose -- not just to check disease but to check side effects.

To be honest, I can't believe.... well, I can't beleive the drug was approved on the 020 data so...

But past that, I can't believe it wasn't approved without a REMS program requiring education. The casual community oncologist trying this drug is going to kill patients. Provenge scored a 1,500 pt follow-up trial on a % point difference in stroke completely explainable by natural stroke hazard rates in their population. This drug kills or leaves people without GI tracts in 13% of patients and it gets only a black box.

While folks argue the side effects collectively are no worse than chemo, I think they miss the point. Even if I grant their argument, the side effects are very different from chemo and present in a completely different way. Except for some chemo cardio effects, most AEs for cehmo go away when you withdraw treatment. Ipi is different. Ipi's side effects don;t go away without counteracting treatment. Worse, a patient who has G1/2 AEs during treatment can lose their colon weeks to months after the last dose. Oncologists have no training or frame of reference in looking at such things.

I won't argue that ipi shouldn't have been approved. I will argue it needs a required REMS program -- at least for the first couple of years of use in each indication.


(EDIT: Looks like from Langreth's article there is a REMS. Thank goodness.)