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POMALYST? What happened to Actimid?

Posted on January 08 2013 by Pat Killingsworth | 1,238 views

I emailed my Celgene contact, Greg Geissman, last evening after learning that pomalidomide’s trade name would be POMALYST.  My question:  What happened to the anticipated trade name, Actimid?

Actimid, wow, blast from the past, I think we stopped using that proposed name a few years back. We had been simply going by the generic name until we were able to announce the new name today. 

Greg

A few years back?  I found Actimid used for CC-4047 (pomalidomide) as far back as 2002 in a Celgene press release:

MONTREAL, QC — July 8, 2002 — Celgene Corporation announced today that investigators from Guy’s Hospital in London presented interim data at the 31st Annual Meeting of the International Society for Experimental Hematology from an ongoing Phase I/II trial of Actimid (CC-4047) in relapsed and refractory multiple myeloma. Steven Schey, M.D., and his colleagues reported that Actimid demonstrated anti-tumor activity in multiple myeloma and has an acceptable toxicity profile.

“Actimid was well tolerated and active in this population of heavily pretreated multiple myeloma patients,” said Steven Schey, M.D., Clinical Director of Hematology and Transplants at Guy’s Hospital. “We were encouraged to observe that, although this trial was not designed to detect an effect on quality of life, patients described a subjective improvement in their well being early in treatment.”

But as Greg explained, somewhere along the line the company decided to use the “generic name,” pomalidomide, as the default name.  Not sure what was wrong with Actimid, but I’m sure some very pricy consultants made a good buck tossing that name out and helping to designate POMALYST as the new, trademarked name.

My question is this:  If Actimid/CC-4047/pomalidomide/POMALYST was effective back in 2002–way before Thalomid and Revlimid were even FDA approved–why is the drug only being reviewed for FDA approval now?

Names are just names.  But by multiple myeloma standards, pomalidomide is a great drug.  Why has it taken a dozen or more years to get this drug to multiple myeloma patients outside of a few clinical studies?

I’m just asking…

Feel good and keep smiling!  Pat

10 Comments For This Post

  1. Bonnie Tesh Says:

    This is unbelievable! How many people could have benefited from this drug, suffered less, and I’ll say it, survived, had this medication been available?

  2. Pat Killingsworth Says:

    Again, I don’t want to jump to conclusions or seem ungrateful. But if someone can come up with a better explanation about the delay, please do. I know it has been working for one of our fellow myeloma celebrities, Minnesota Don, for over four years in an extended clinical study at Mayo Clinic…

  3. suzierose Says:

    why are we quibbling about a name? The drug is coming 2 market! That is the most important thing. Being available to MM pts, irregardless of the ‘branded’ name.

    This is a drug that works, works well…I am happy about it being able to be on the market independet of name.

    However, names have to be thought about in terms of how they are read on a prescription and perhaps there are other drugs that could be mistaken for a scrawl of Actimid?

  4. Nick van Dyk Says:

    I’m a novice in the drug approval process, Pat, but I think it’s actually rather common for a drug to take ten years to go through Phase I, II and III trials before approval. Particularly in a disease where there just aren’t that many patients (relative to, say, Lipitor). it simply takes a long time for enough patients to be entered into studies to confirm drug efficacy, dosing, and side effects.

    It’s interesting to me that Revlimid hadn’t even been FDA-approved until 2006 and Pom was in trials at least four years before that…

    And in what must be up there among greatest ironies of all time, it’s because of Thalidomide’s ORIGINAL use that the whole FDA approval process was put in place…

  5. Pat Killingsworth Says:

    Not “quibbling,” Suzie. I find the process fascinating. So no “we,” its me! Come on… The name thing is interesting. How sometimes a trade name sticks and other times not. And it does effect us a bit. Communication is important. As a writer, I just like to be consistent. Little quirks drive me crazy with this stuff. For example, why is it “RVD? Docs in their studies use lenalidomide and bortezomib. Why isn’t it LBD or BLD? I figured someone who immerses herself in this stuff would understand! But I understand why you or one of these docs wouldn’t care. You are right–it really doesn’t matter. But it is sloppy and makes a tough to follow subject a bit harder to understand.

  6. Pat Killingsworth Says:

    Nick is correct on both counts. Yes, can take ten years–but process is speeding up. And yes, Nick sees my point. I just take a bit more cynical view of the process. I am not anti-pharma. BUT come on… The better drug is held back while another is approved. Where is the CSI instinct? It would make for an interesting story. Maybe I will land an interview from someone high-up enough at Celgene to help explain the process and why things have turned-out this way. But yes, I’m glad both drugs (all three, actually) are available. And I’m not going to knock-myself-out researching some of these things that, as Suzierose stresses, doesn’t change the fact that our docs will now have access to another effective drug.

  7. Stevethalomid Says:

    I worked on both Actimid and Revlimid. Revlimid was a massive improvement over other available oral therapies for myeloma. Actimid can help some patients where Revlimid is not suitable. However it is not without some difficult questions associated with risk/benefit issues. I am glad that the drug is being moved forward to bolster the ever increasing armory of agents active in myeloma. Ironically, this post is being written having literally spoken 1 hour ago to a carer of a myeloma patient who is now being sustained by transfusions alone having been through multiple chemo regimens and a bone marrow tx. Actimid was the first thing that came into my head as a potential option. I have seen patients without hope from myeloma given years of good quality of life because of Celgene and its research-please cut them some slack as they move drugs forward.

  8. Pat Killingsworth Says:

    Fair enough. But honestly, I think I have gone pretty easy on them. Maybe they couldn’t afford to advance two IMiDs at the same time. If that’s the case, the perfect investor timeline is only a coincidence. I’m not questioning (or unappreciative) of all that work so tirelessly to help develop these drugs. I’m questioning the timing decisions, made by a few at the top that are responsible to investors. The ying and yang of the U.S. drug industry…

  9. Mike Says:

    It’s my understanding that once the competition from EntreMed was taken care of, Celgene hoped to target Revlimid (which at that point hadn’t yet been shown to cause birth defects and thus they hoped wouldn’t require STEPS) at myeloma and use Actimid (as it was still known back then) in prostate cancer because men can’t get pregnant. It was only when the prostate cancer trial was weak that they came back to myeloma.

  10. Pat Killingsworth Says:

    I have never heard that explanation before; nor did anyone from Celgene or the IMF bring that up. Interesting…

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