OUCH! I’m not sure why the FDA would post a negative review of carfilzomib (proposed trade name Kyprolis) two days before their scheduled committee review of the drug.
But they did and it wasn’t pretty! Apparently, regulators are concerned with a high percentage of fatalities among clinical trial participants.
The online version of The Washington Post summed things up best:
WASHINGTON — The toxic side effects of an experimental cancer drug from Onyx Pharmaceuticals may outweigh its benefits for patients with a type of blood cancer, federal health regulators said Monday.
The Food and Drug Administration warned that patients in a company study of the drug had a high rate of heart and lung side effects, some which were fatal. The FDA posted its review of carfilzomib online ahead of a meeting Wednesday, where its panel of cancer experts will recommend whether the drug should be approved.
Despite the negative tone of the review, some analysts said they expect the FDA’s panel of outside experts to take a more favorable view. FDA panels are mainly comprised of practicing physicians from leading universities and hospitals.
BMO Capital Markets analyst Jim Birchenough said he expects “panel members to be more constructive toward the carfilzomib data package.”
Please remember that news like this breaks first among business publications. For example, Onyx Pharmaceutical stock fell 4.1% yesterday as the news broke. That doesn’t seem like a very big drop. I did read another pharma business blog that actually issued a buy recommendation. Hmm. Maybe this be that big a deal…
Here is a link to the AP/Washington Post story:
FDA review of Onyx Pharmaceuticals cancer drug focuses on toxic side effects
And here is a link to a Bloomberg Buisnessnews story as well:
Onyx’s Cancer Drug’s Risk May Outweigh Benefit, FDA Says
I had been hearing rumors that there might be a hiccup with carfilzomib’s development. What I didn’t expect to hear was that patients might be dying from complications associated with using the drug. I will keep you updated as soon as I learn more…
Feel good and keep smiling! Pat
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