This is another life extending drug for patients with myeloma who have received other treatments that have not worked.  The drug is available via restricted distribution program under a Risk Evaluation and Mitigation Strategy (REMS) called “POMALYST REMS” which means prescribers and pharmacists have to be certified and patients sign an agreement to comply with the requirements.  There’s quite a list of side effects as well.  BD

Celgene Corp.
’s therapy for a deadly blood cancer that will sicken more than 22,000 people in the U.S. this year won U.S. regulatory approval.

Pimageomalyst, or pomalidomide, was approved for multiple- myeloma patients who have tried and failed on at least two other drugs, including Celgene’s Revlimid and Takeda Pharmaceutical Co.’s Velcade, according to a statement today from the Food and Drug Administration. Pomalyst may generate sales of $1.1 billion in 2017 for Summit, New Jersey-based Celgene, according to the average of 12 analysts’ estimates compiled by Bloomberg.

Pomalyst will carry a boxed warning that the product can cause blood clots and that pregnant women shouldn’t use the drug because it can lead to life-threatening birth defects. Women of childbearing age who take the treatment must comply with pregnancy testing and both males and females have to adhere to contraception requirements, the FDA said.


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