Alright Pharma Investors, today I am going to run through a comparison of some companies that all have drugs in development for Elderly patients with AML. What is surprising is that all of the drugs also either have completed or are in Phase II trials, but have yet to run a Phase III trial.
First up: Genzyme’s Clolar
I remember listening to the FDA panel meeting in disbelief when they voted against approving this drug back in September. At first I thought I was dreaming, but alas I came to my senses and realized that the FDA had actually voted this drug down. The drug is already prescribed to children that have refractory ALL and Genzyme was seeking approval with only a Phase II clinical trial. So let’s go over the data real quick.
In the CLASSIC II trial elderly patients that were unlikely to benefit from standard induction chemotherapy had an Overall Response Rate (ORR) of 46% and a 30 day mortality rate of 9.8%. Now to me the data was a grand-slam, but apparently the FDA doesn’t agree with me, because in September the FDA’s Oncology Advisory Panel voted for Genzyme to run another Phase III clinical trial. I was actually a little baffled at the FDA’s call on this one, yes the trial wasn’t large, but the benefits are so great that I couldn’t believe the FDA didn’t get this thing on the market as soon as possible. Granted, the trial was only a Phase II trial and was also unrandomized, but when you are talking about a 46% ORR you kind have to wonder what is going through the FDA’s heads at this point. Wait, I know what the FDA is thinking, they are worried that the data isn’t up to snuff. You see, the FDA drug reviewers raised concerns about the population in Genzyme’s trial, noting that it was not a study of elderly AML patients who were not fit for standard induction chemotherapy because of poor general health. What is ironic however is that Clolar is so prominent that the National Comprehensive Cancer Network even cites the CLASSIC II study run by Genzyme as a potential treatment option for these patients. My general thought on this one is that the drug will only get approved after Genzyme wastes more money and time by running another long drawn out clinical trial just to satisfy the FDA.
cont’d on next page
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