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Celgene Submits Pomalidomide For FDA Approval

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Published: Apr 26, 2012 7:18 am

Celgene Corporation announced this morning that it has completed submission of its application to the U.S. Food and Drug Administration (FDA) for the approval of pomalidomide as a treatment for relapsed and refractory multiple myeloma.

If the FDA approves pomalidomide based on this application, Celgene could begin marketing pomalidomide in the United States as early as this fall.

Pomalidomide (Pomalyst), which belongs to the same class of drugs as thalidomide (Thalomid) and Revlimid (lenalidomide), is being developed by Celgene (NASDAQ: CELG) for the treatment of multiple myeloma and myelofibrosis.

Results from the latest clinical trials involving pomalidomide in relapsed/refractory multiple myeloma were presented at the American Society of Hematology meeting last December (see related Beacon news).  Physicians as well as industry analysts have responded positively to the drug’s performance, particularly among patients previously treated with both Revlimid and Velcade (bortezomib).


News articles about:
- Pomalyst (pomalidomide)

Forum discussions about:

- Pomalyst (pomalidomide)

Under the FDA’s standard review process, the agency must decide whether to approve a drug within 10 months of the time the drug is submitted for review.  However, the FDA can grant priority review to drugs that offer significant advances in treatment, particularly for diseases in which there are inadequate treatment options. If the FDA grants pomalidomide priority review, the agency would need to complete its review of the drug within six months.

Thus, if the FDA approves pomalidomide based on the application Celgene recently submitted, the drug could be available for use in the U.S. by the last quarter of 2012 or early 2013.

Celgene plans to submit a similar application to the European Medicines Agency by the end of June.

Along with carfilzomib (Kyprolis) – which works similarly to Velcade – pomalidomide is considered one of the most promising new myeloma treatments that could be approved by the FDA in the next few years.

For more information, see the Celgene press release.

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  • Myeloma Beacon Staff said:

    For readers interested in more specific details about the timing of the pomalidomide new drug application to the FDA ...

    In its press release yesterday, Celgene was not specific about the timing of the new drug application. The company only reported that the submission had taken place.

    However, since the press release was made public, Celgene representatives have clarified that the application was submitted "in early April."

  • Gratia Williams said:

    My spouse, who has been treated with Velcade effectively (prior to SCT), but did not respond well to Revlimid (prior to SCT or as a maintenance drug post-SCT), is currently on Pomalidomide (Cycle 6). So far, his disease is stable, but at a price. He has experienced a low white blood cell count (two shots of Neupogen have been required so far), which is a common side-effect of the drug that brought on pneumonia and a terrible case of shingles. Leg cramps are another unwelcome side-effect. His oncologist continues to adjust the dosage of Pomalidmide (as part of a clinical trial) to see if an acceptable WBC can be maintained without compromising the efficacy of Pomalidomide.

    Although I am grateful that Pomalidimde is available through a clinical trial, is an oral drug (versus IV)and may soon be FDA approved, at the same time I perceive it to be (although I may be mistaken) merely a small, incremental step forward and a clear example of a pharamceutical company re-purposing a drug in order to drive profits.

  • Mark said:


    IMO your comment about pomalidomide is fairly accurate. The data I see shows a minority of patients respond to pomalidomide that are no longer responding to Revlimid or in a small number of cases some patients that never responded to Revlimid do respond to Pomalidomide. Fortunately I have never needed to take Revlimid, pomalidomide, or thalidomide. It is great that it will hopefully be available to all patients in the US by the end of the year, but it is far from a "game changer" for the majority of patients. It seems to have a lot of the bad side effects associated with Revlimid. Despite all the hype about new therapies for Myeloma, the last FDA approved drug was Revlimid in 2006. The next FDA approved drug will either be pomalidomide or carfilzomib, which is just a different drug in the same class of drugs as Velcade. Carfilzomib also seems to be far from a "game changer" for the majority of patients from the studies I have read. We deseperately need some less toxic Myeloma therapies, that is for sure.


  • james knight said:

    Pomalidomide, i am relapsed after a stem cell transplant down at UT San Antonio and went up to UAMS in Jan for 5 months in and out patient, I have lite chain Multiple Myeloma and need to know whats left for those of us trying to buy time on earth and some quailty of life when everything left is not working, is there anybody reading this on Pomalidomide drug test at Mayo Clinic or UAMS Little Rock Arkansas, I am trying to get on a new drug trial closer to my caretaker in groveland Florida, got called back to UAMS for a BMB and MRI and waited and waited for acceptance to the drug test they were running for Pomalidomide with bad results, Drs office red tape broke me or they dumped me out not sure still? Currently trying to get on something in Florida where could drive back and forth to Clinic as UAMS wastes to much money due to overcrowding and bad patient to doctor ratio due to overcrowded faciltiy. Anybody with ideas call me 361 354 0572 currently waiting on UAMS to send my med records to Florida Cancer Specialists so i can at least get a local oncolgists in Groveland Florida to help me with this mess, am relapsing fast as urine is foaming bad, back pain, cough etc, please call if got any ideas on last breath MM lite chain about to take me out, James Knight Beeville Texas Help me please if you can!!!!