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FDA Approved for RRMM: Pomalidomide (Pomalyst)




SUMMIT, N.J.--(BUSINESS WIRE)--Feb. 8, 2013-- Celgene Corporation (NASDAQ: CELG) today announced the U.S. Food and Drug Administration (FDA) has approved POMALYST® brand therapy (pomalidomide) for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and bortezomib and have demonstrated disease progression on or within 60 days of completion of the last therapy.


Approval is based on response rate. Clinical benefit, such as improvement in survival or symptoms, has not been verified.


Supporting the approval were the results of MM-002, a phase II, randomized, open-label study evaluating pomalidomide (4 mg once daily on days 1-21 of each 28-day cycle) plus low-dose dexamethasone (40 mg per day given only on Days 1, 8, 15 and 22 of each 28-day cycle for patients 75 years or younger, or 20 mg per day given only on Days 1, 8, 15 and 22 of each 28-day cycle for patients greater than 75 years of age) versus pomalidomide (4 mg once daily on days 1-21 of each 28-day cycle) alone in patients with relapsed multiple myeloma who were refractory to their last myeloma therapy and had received lenalidomide and bortezomib.


MM-002 is a phase 1/2 trial conducted at 18 centers in the US and Canada, initiated in December 2009.

 

Learn more:

https://ir.celgene.com/press-releases-archive/press-release-details/2013/US-Food-and-Drug-Administration-Approves-POMALYST-pomalidomide-for-the-Treatment-of-Patients-with-Relapsed-and-Refractory-Multiple-Myeloma/default.aspx



02/08/2013: FDA Approval

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204026Orig1s000ltr.pdf










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