After Maxim's phase 3 met its endpoints the fda still did not approve Ceplene because: "Ceplene improves leukemia-free survival but not overall survival in adult AML patients in first remission". (This quote is not from the fda but from a summary I found - there are similar quotes from the fda.)
Does anybody know of anything new that has happened since then to influence the emea to reach a different decision?
Glaxo hid the truth that most ulcers were caused by a bacterium and rubbished the Australian researcher, John Warren, who showed this, for over ten years in order to protect their Zantac franchise.
Big Pharma has been instramental in the undermining of good potential new cancer fighting drugs getting to market. Just think, "chemo", and all the companies that are involved in it that stand to lose billions. This has been debated heavily on the DNDN and GERN boards. The greedy bastards would rather see people suffer through their dinosaur therapies then get on board with the new generation of safe less evasive cures!
The FDA really SHOULD have approved Ceplene based upon safety and efficacy.
Asking for proof that it wasn't the effect of IL2 in my opinion was unfair, because IL2 is used extensively and is already proven safe. What did the FDA stand to lose?
Maybe some big pharma bucks had something to do with the "outcome" and "decision" by the FDA?
In fact there exist some cancer therapy areas which show larger steps than other areas (e.g. juvenile leukemia). However the majority of all cancer therapies shows small step progress only. Of course also chemos have some benefits, but they demand a painful price in the quality of life with a significant number of unspecific and serious side effects. Any further step there is an advantage. Antibodies are promising but they do not belong to chemotherapy. Regarding the mentioned vascular disrupting agents: also EPCT has with its Axiza such agent. As far as EPCT's Ceplene is concerned I had said it represents a good step forward with respect to both the remission phase and the quality of life. That appears to me an advantage over the chemotherapeutics.
Over decades the cancer drug therapies show a small step-by-step progress only (if any at all), not break throughs. Also Ceplene represents this kind of stepwise progress thus also a respective value. In this framework is a discussion of "overall survival" versus "leukemia free survival" rather theoretical. The cited statement "you would expect a beneficial effect on overall survival from an increase in leukemia free survival" refers to a logical therapeutic conclusion of this matter. In general health authorities approve the currently best therapy with regard to its relative benefit-risk ratio. This also includes the quality of life , in partcular essential for the cancer patients.