ARTICLE | Company News
New approvals for Amgen's Kyprolis
January 22, 2016 2:09 AM UTC
Amgen Inc. (NASDAQ:AMGN) said FDA approved an sNDA for Kyprolis carfilzomib to treat relapsed multiple myeloma (MM) in combination with dexamethasone or Revlimid lenalidomide plus dexamethasone in patients who have received one to three prior therapies. The agency also approved Kyprolis as a single agent to treat MM in patients who have received at least one prior therapy. The latter decision converts to full approval the accelerated approval that FDA granted to the second-generation selective proteasome inhibitor in 2012.
Celgene Corp. (NASDAQ:CELG) markets Revlimid to treat MM. ...