
Arzerra approved by US FDA for leukaemia
pharmafile | January 20, 2016 | News story | Research and Development, Sales and Marketing |Â Â Afrezza, CLL, FDA, Genmab, Novartis, chronic lymphocytic leukaemia, ofatumumab, sBLA, supplementary biologics license applicationÂ
The FDA has signed-off a supplemental Biologics License Application (sBLA), meaning Arzerra is approved 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 leukaemia (CLL).
The application for Arzerra (ofatumumab) was submitted by Novartis – who acquired the product from GSK – under a collaboration between the Swiss firm and the Danish company, Genmab.
This FDA approval is based on data from an interim analysis from a Phase III study, PROLONG, which evaluated Arzerra maintenance therapy versus no further treatment in patients with a complete or partial response after second or third line treatment for CLL.
A total of 474 patients were included in the analysis. Patients who received Arzerra maintenance treatment lived 14.2 months longer without their disease worsening than patients who received no further treatment. Median progression-free survival as assessed by the investigators was 29.4 months for the Arzerra treatment arm and 15.2 months for the observation arm.
“The approval of Arzerra in the US as extended treatment provides patients with relapsed CLL with a new treatment option that can help delay disease progression,” says Jan van de Winkel, Genmab’s chief executive.
Lilian Anekwe
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