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.
P
omalyst, 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.
http://www.bloomberg.com/news/2013-02-08/celgene-wins-approval-of-drug-to-treat-deadly-blood-cancer-1-.html
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