Friday, April 27, 2012

Pomalidomide Submitted for FDA Approval

I'm so delighted.  Pomalidomide, by Celgene, is the new, innovative anti-cancer drug which has kept my myeloma stable for four years now, in a drug trial.  That trial and other trials have demonstrated that pomalidomide is a powerful combatant in the fight against myeloma.  When pomalidomide is available to everyone it will benefit many, many patients.  For some, it will save their lives.

If all goes very well, the FDA could approve pomalidomide as soon as this fall.

Here is a great article on Celgene's April 26 announcement, by the International Myeloma Foundation.

The other very promising drug on the immediate horizon is carfilzomib, by Onyx, submitted for FDA approval last September and well on its way to approval.  It uses a different mechanism than pomalidomide for fighting myeloma, and there is even a trial underway to determine how well they might work together.

Things are happening.  Never stop hoping.


  1. Hi Don, I follow your blog occasionally. I just progressed to active myeloma after 8 months smoldering. I am a 49 year old guy. I have chosen to enter a carfilzomib trial for newly diagnosed patients at the NIH with Dr. Landgren. The other option was rev/dex with a fast track to a SCT. I feel lucky to get in the NIH trial as the results there and elsewhere have been excellent. Thanks for your blog and courage. Terry

  2. Terry, I certainly do wish you the best in the carfilzomib trial. Be well, have hope.


  3. Thanks, Don. I am steeling myself for the next two years with the carfilzomib trial. I report this Thursday for the first administration of the meds. it's scary but I can't wait to knock those damned PC's out of the park! Also, in reviewing your history, it seems you never had a SCT? I have been told that this specific trial could potentially call into question the almost automatic use of SCT's for those under 65. I hope to avolid one long enough for at least an effective "cure". Thanks again for everything. Terry

  4. You are correct. Almost nine years now and no SCT. There is a raging debate among myeloma doctors whether newly-diagnosed patients should get on the path for SCT, or start doing the other available treatments one at a time. My myeloma seems to be slow-moving (so far) so I've taken the conservative approach.

    If pomalidomide eventually fails, I will most likely try another drug rather than SCT. I'm 71 now, too, getting a bit old for SCT and hoping to be much older when/if pomalidomide fails.

  5. Don, this is great news! My Rev is still working for me, but it is nice to know that yet another drug is available when the time comes!

  6. Thanks Don for sharing and for keeping
    Ing us updated with such great information .