Posted by Michael Wonder on 05 Jun 2017
Genmab announces U.S. FDA approval of Arzerra (ofatumumab) as extended treatment for recurrent or progressive CLL
19 January 2016 - Arzerra previously approved to treat previously untreated and refractory chronic lymphocytic leukaemia indications in the US.
Genmab announced today that the U.S. FDA has approved a supplemental biologics license application for the use of Arzerra (ofatumumab) for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL). The application was submitted by Novartis under the ofatumumab collaboration between the two companies.
This FDA approval is based on data from an interim analysis from a Phase III study, PROLONG (OMB112517) which evaluated ofatumumab maintenance therapy versus no further treatment in patients with a complete or partial response after second or third line treatment for CLL.
