The CHMP approval is for the second-line setting, the same indication for which Arzerra was approved by the FDA in Oct 2009 (#msg-42935958) under the Accelerated Approval program.
The Arzerra program also includes first-line CLL and autoimmune diseases such as RA—see the prologue of #msg-40412567 for details.
GSK licensed Arzerra (a/k/a/ ofatumumab; f/k/a/ HuMax-CD20) in 2006 in one of the largest biotech deals ever for any company (#msg-15652707).
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”