The More I Search, the More Mind-Boggling the Adcom's Decis ion to vote against MCNA becomes. A quote from the FDA:
"As for FDA, although there may be problems with the clinical trials intended to support a sponsors original proposed indication, if a compound has activity its incumbent on us to work with the sponsor to try to get the drug to the public for areas of high unmet medical need, Office of Hematology and Oncology Products Director Richard Pazdur said in an interview."
Here is what I find extremely interesting in relation to the above quote. In 2015, the FDA approved Farydak to treat 3rd line plus multiple myeloma patients, after the Adcom voted against its approval.
I currently work in pharmaceutical forecasting for a company who is a major player in the multiple myeloma space. There is a MUCH higher unmet need in the bladder cancer space than in the multiple myeloma space; the comparisons are not even close. At the time the FDA went against the Adcom’s recommendation and approved Farydak, the following treatments were available and had long-standing successful histories in treating multiple myeloma:
Velcade - frontline therapy
Revlimid - relapse/refractory
Pomalyst - third line plus
Kyprolis - third line plus
Thalomid - very rarely used but available
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Daratumimab - phase III clinical trials were ongoing in 2015
Elotuzimab - phase III clinical trials were ongoing in 2015
My point of posting this is just to show that Farydak was able to get approved after an FDA adcom rejection, with all of the above treatments available!! There has been nothing in the bladder cancer space since God-awful Valstar in 1998!!! This defines high unmet medical need!!