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.
Pomalyst, 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.