FDA expands use of GlaxoSmithKline, Genmab's Arzerra to include first-line treatment of CLL

GlaxoSmithKline and Genmab announced that the FDA expanded approval for Arzerra (ofatumumab), in combination with chlorambucil, as a first-line treatment for patients with chronic lymphocytic leukaemia (CLL) who are unsuitable for fludarabine-based therapy. Genmab CEO Jan van de Winkel noted that Arzerra "is the only therapeutic CD20 antibody approved in combination with chlorambucil for first-line CLL and as a monotherapy for CLL refractory to fludarabine and alemtuzumab."

According to the companies, the FDA decision was based on data from the PHASE III COMPLEMENT I study involving 447 treatment-naïve patients with CLL for whom fludarabine-based therapy was deemed inappropriate. Patients were randomised to receive either Arzerra plus chlorambucil, or chlorambucil alone. Results demonstrated that median progression-free survival (PFS) was significantly improved among patients in the Arzerra group, who achieved PFS of 22.4 months, versus 13.1 months for those only administered chlorambucil.

GlaxoSmithKline and Genmab noted that with the exception of neutropaenia and leukopaenia, the overall rate of non-infusion-related reactions that were Grade 3 or higher in the Arzerra group was similar to chlorambucil alone. Meanwhile, infusion reactions (IRs) were observed in 67 percent of patients in the combination treatment arm, and the companies noted that 10 percent of IRs were Grade 3 or greater.

The application for expanded approval of Arzerra was evaluated by the US regulator under a priority review designation. The companies filed an EU application last October to market Arzerra in combination with an alkylator-based therapy for first-line use in the same patient population.

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