The FDA stamped an approval on Celgene's Pomalyst, a new oral treatment in a growing armament of meds against the blood cancer known as multiple myeloma.
Celgene captured the center ring at the J.P. Morgan conference on its opening day Monday. Company CEO Bob Hugin boldly mapped out a 5-year plan to double sales and highlighted upbeat Phase III data on its psoriasis drug apremilast that he believes will set the stage for regulatory approval on both sides of the Atlantic.
Celgene laid out its case for its multiple myeloma blockbuster hopeful pomalidomide at the American Society of Hematology meeting, boasting of an improved promise of overall survival, progression-free survival and overall response rate among a group of very sick patients who had failed either Revlimid or Velcade.
The data were "highly statistically significant and clinically meaningful," noted Celgene, which is pushing for an approval to use the drug among treatment-resistant patients. The safety review board recommended that patients in the control arm whose myeloma hadn't progressed should be provided the experimental drug combo.