PFE's tofacitinib. This is a close call and sometimes I have to practice both sides of the issue like my lawyer friends until I come to closure on my view. After all, these committee decisions are life and death for some, especially in this case. I just stated the detailed safety issues in my view in my SI post (that can be dealt with in the label).
Here is what I posted on SI regarding my 'waffling'.
"I am still pondering somewhat the efficacy concerns, and read up a bit more on the types of lymphoma observed. I will reserve my right to change my opinion again, but this is a close call. I stated plurality (in favor for) initially on your board, more recently here "a close vote". Not all that different I guess.
Tofacitinib is kinda like some other immunosupressants. Nice to have them in the arsenal for RA docs, but I sure would hate to be in a position to have to use the drug myself with the risk. Kinda like Tysabri without the extent of efficacy but the PML risk (now a JC virus test though). The CNS lymphoma cases are worrying me, and how to treat that.
Now I am more bullish on the INCY compound than the PFE compound. But, want to see the long term tox in animals for INCY, and they longer term exposures and results in man for immunosuppression risk."
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