EU clears front-line use of GlaxoSmithKline, Genmab's leukaemia drug Arzerra

GlaxoSmithKline and Genmab announced Thursday that European regulators expanded approval for Arzerra (ofatumumab), in combination with chlorambucil or bendamustine, to include treatment-naïve patients with chronic lymphocytic leukaemia (CLL) for whom fludarabine-based treatment is deemed inappropriate. Genmab CEO Jan van de Winkel indicated that the companies plan to launch the CD20 targeting antibody under its new indication "in the coming months."

The drugmakers said the decision, which follows a recent positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), was based on results from the Phase III COMPLEMENT 1 study testing Arzerra plus chlorambucil versus chlorambucil monotherapy in CLL patients considered unsuitable for fludarabine-based therapy. Findings showed that the combination treatment improved median progression-free survival (PFS) by a significant 71 percent, with Arzerra-treated patients achieving PFS of 22.4 months, compared with 13.1 months for those in the chlorambucil group.

GlaxoSmithKline and Genmab said the approval was also based on data from a mid-stage trial testing the combination of Arzerra and bendamustine versus bendamustine alone in 44 patients with previously untreated CLL considered inappropriate candidates for fludarabine-based treatment. Results demonstrated that patients in the Arzerra group achieved an overall response rate of 95 percent and a complete response rate of 43 percent, the companies said.

In April, the FDA expanded Arzerra's approval to include the same indication. Meanwhile, the therapy was previously cleared in the EU for the treatment of patients with CLL refractory to fludarabine and Sanofi's Campath (alemtuzumab). Arzerra is part of a portfolio of medicines that GlaxoSmithKline recently agreed to sell to Novartis for as much as $16 billion, with the deal expected to close in the first half of 2015.

Last week, GlaxoSmithKline and Genmab announced that Arzerra missed the main goal of PFS in a Phase III study testing the drug in 122 patients with bulky fludarabine-refractory CLL. Earlier this year, the companies reported that Arzerra failed another late-stage trial evaluating the drug against Roche's MabThera (rituximab) in patients with relapsed or refractory diffuse large B-cell lymphoma.

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