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Battle Of The New Multiple Myeloma Novel Therapy Agents: Why I Expect Carfilzomib To Gain FDA Fast Track Approval Sooner Than Pomalidomide

Posted on July 02 2010 by Pat Killingsworth | 588 views

One of our readers recently sent me the following e-mail:
Hey Pat,

Great job down at ASCO. I have a question: while you were down there, did you get a sense about when Celgene might push for pomalidomide’s approval?
Thanks. Feel good.
— Gregg

I responded this way:
Hi Gregg-

Pomalidomide seemed a bit “under the radar” (at ASCO). Just my perception. A contact from Onyx just got back to me saying they are pushing hard for approval by this time next year. I’m not sure why Celgene doesn’t seem to be pushing harder. But remember, Rev still isn’t approved for newly diagnosed patients after all of this time. Hope that isn’t a sign of how long it will take pomalidomide to get out. Stats look super–so why aren’t they (Celgene) promoting and pushing harder? Puzzling. Might just be style. I will make a few calls. Mind if I post your question and update my response on the blog?

Gregg said “sure,” then went on to express concern that Celgene wasn’t motivated enough to push for pomalidomide’s immediate approval.

I can’t say I disagree!  I don’t want to seem cynical, but there is little doubt in my mind carfilzomib will gain FDA approval long before pomalidomide—even though pomalidomide’s numbers are at least as good or better than those for carfilzomib. The answer: Onyx is racing to get carfilzomib to market, because the existing proteasome inhibitor, Velcade, is manufactured by a different competing company, Millennium.

Pomalidomide is manufactured by Celgene, which also produces both Thalomid and Revlimid. Where is the motivation to rush pomalidomide to market?

I know, I know—how could I even think such a thing? I understand Mayo docs have been working day and night to help prove pomalidomide is a better Safer drug than either Thalomid or Revlimid—and from the data I viewed at ASCO they are succeeding! But where is the urgency? Onyx execs are pushing, pushing, pushing for fast track approval. I just don’t see/sense the same drive from Celgene.

Onyx isn’t concerned about Millennium or Velcade—the company simply wants to get their (hopefully) profitable drug to market as quickly as possible. Will it render Velcade obsolete? No! Both drugs will still have an important place in day to day patient therapy. But there is no question the approval of carfilzomib will hurt Millennium’s bottom line. Can’t the same be said for Celgene’s pomalidomide? Except in this case, the introduction of this new novel therapy agent could hurt sales of Thalomid and Revlimid—the company’s own drugs!

I hope I’m wrong. This is just my perception/opinion—and it may be as simple as carfilzomib is farther along in the approval process.  I am in the process of trying to run down an official response from Celgene—never an easy task when you are trying to get an answer to any controversial question from a large pharmaceutical company.  The good news: A growing access to pomalidomide clinical trials could help take the sting out, helping more patients gain access to pomalidomide prior to FDA approval. I’m sure Celgene is following industry standards while moving steadily toward approval. But are they moving/pushing hard enough?

Have a great 4th of July weekend!  I will be writing, both here and on, all three days—so don’t forget to check back from time to time.
Feel good and keep smiling! Pat

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