GSK, Genmab Get FDA Approval For Arzerra As First-Line Treatment For CLL

(RTTNews) - GlaxoSmithKline plc (GSK, GSK.L) and Genmab A/S said Thursday that the U.S. Food and Drug Administration has approved a Supplemental Biologic License Application for the use of Arzerra, a CD20-directed monoclonal antibody, in combination with chlorambucil for the treatment of previously untreated patients with chronic lymphocytic leukemia for whom fludarabine-based therapy is considered inappropriate.

The FDA approval of the first-line indication is based on results from a Phase III study which demonstrated statistically significant improvement in median progression-free survival in patients who received the combination of ofatumumab and chlorambucil compared to patients who received chlorambucil alone.

Arzerra, which is being developed under a co-development and collaboration agreement between Genmab and GSK, is also indicated as monotherapy for the treatment of patients with CLL refractory to fludarabine and alemtuzumab.