Ofatumumab (Arzerra, GlaxoSmithKline and Genmab), which is already approved for use in the treatment of chronic lymphocytic leukemia (CLL), has failed in a phase 3 trial in a subgroup of patients with this disease.
Specifically, the negative trial failed to show any improvement in progression-free survival when ofatumumab was compared with physician's choice of treatment in patients with bulky fludarabine-refractory CLL. The median progression-free survival, as assessed by the Independent Review Committee, was 5.36 months for ofatumumab and 3.61 months for physicians' choice (hazard ratio, 0.79; P = .267).
"Although ofatumumab performed broadly in line with previous data, today's result is disappointing. Based on this result, we do not anticipate applying for a label expansion for ofatumumab in this specific refractory CLL population," said Jan van de Winkel, PhD, chief executive officer of Genmab.
This trial, known as OMB114242, had been conducted by the manufacturer in order to meet the requirements from the European Union Commission for the conditional approval of ofatumumab for the treatment of CLL in patients who are refractory to fludarabine and alemtuzumab (this is the current approved indication in the European Union).
In the United States, ofatumumab was recently granted full approval by the US Food and Drug Administration for use in combination with chlorambucil in CLL in previously untreated patients who are not candidates for fludarabine-based therapy. The drug had a breakthrough therapy designation for this indication.
It had previously been granted accelerated approval in 2009 for the treatment of patients with CLL refractory to fludarabine and alemtuzumab (Campath).
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