[Pete N]

Estimated FDA approval date for pomalidomide?

by Pete N on Tue Dec 20, 2011 11:36 am

The subject line says it all. I see from ClinicalTrials.gov that pomalidomide [Pomalyst] is currently being tested in a few phase III trials and many phase II trials.

Assuming the trials are successful is it expected that approval will come in 2012, 2013, or later?

Pete N

[Dr. Ken Shain]

Re: Estimated FDA approval date for pomalidomide?

by Dr. Ken Shain on Thu Dec 22, 2011 10:23 am

At this point, it is up to the FDA. If Pom (Celgene) is granted accelerated approval it may be "available" in 2012. If not, more studies will need to be done and its availability will be delayed. This is what recently happened to Carfilizoimib (Onyx). So, for carfilizomib more patients need to be examined. Therefore, it will only be available to patients on clinical trials.

I do not know that details as to why Carfilizomib was not given accelerated approval. Nor do I have any idea of the status of Pom in the process at the FDA at this point.

These are both excellent drugs for a population of patients who remain with limited options. If it were just up to me, they would be approved. But it is not an easy process and ideally the FDA process is to protect you the patients.

Lastly, please always seek out centers of excellence where clinical trials are available to maximize your care.

Happy Holidays.