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POMALIDOMIDE UPDATE

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The US Food and Drug Administration (FDA) has cancelled the planned November advisory committee (ODAC) meeting for Celgene's pomalidomide application.  Celgene, in a press release, indicated that the pomalidomide application is continuing, which means that a decision with regard to pomalidomide is still expected on or before February 10, 2013.

 So what does that cancellation mean?  Firstly, it is important to note that the FDA is not obliged to convene an ODAC hearing and, in fact, only needs to have a hearing if there are unresolved questions or concerns.  Thus, the first and dominant interpretation is that there are no outstanding issues and that the FDA is on track to make a decision- most likely a positive decision with regard to pomalidomide approval.  The alternate interpretation that the FDA would disapprove pomalidomide without a formal ODAC hearing seems much less likely.

 Thus, I am optimistic that pomalidomide will indeed be approved based upon "unmet need" just as was the case recently for carfilzomib (Kyprolis�).  The ODAC hearing for carfilzomib may have helped the FDA in considering pomalidomide in that the case for the "unmet need" for new drugs to treat myeloma was very clearly and strongly articulated during that hearing.

So, let's keep our fingers crossed for a positive outcome.

2 Comments

Dr. Durie's comments re the FDA and Pomalidomide were very helpful. However, it surprises me that he would have to "read tea leaves" to ascertain the significance of the meeting cancellation.I'm unfamiliar with the details of the processes for moving new drugs forwards (or backwards0, and wonder why some remarks were not made by the FDA accompanying their decision. On the other hand,the Federal Reserve seems preoccupied with communicating their policy decisions more transparently.

The Mayo clinic has had success with pomalidomide and AL amyloidosis in trials. We certainly hope this drug is approved for the MM arsenal of treatments as that is where we get our treatments for AL.
Muriel Finkel
Amyloidosis Support Groups Inc.

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