FDA Approves GSK/Genmab Drug For Chronic Lymphocytic Leukemia
The Food and Drug Administration has approved Arzerra for the treatment of chronic lymphocytic leukemia in combination with chlorambucil, another chemotherapy drug produced by GlaxoSmithKline.
Arzerra is also known as ofatumumab, and it was developed by Genmab in a partnership with GSK. Ofatumumab is a CD20-directed cytolytic antibody, and in 2009 it was given accelerated approval status under the condition that it underwent further trials.
The Phase III study published April 17th showed significant statistical improvement in median progression-free survival in patients who were treated with ofatumumab and chlorambucil, compared to those being treated solely with chlorambucil. For patients being treated only with chlorambucil, median progression-free survival was 13.1 months. For patients being treated with both ofatumumab and chlorambucil, the median progression-free survival number was 22.4 months.
Jan van de Winkel, Genmab’s CEO, spoke on the drug’s approval by the FDA. “We are pleased that Arzerra has been shown to provide clinical benefit and will now be available in the first-line setting. Arzerra, the first approved therapeutic created by Genmab and developed in collaboration with GSK, 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,” said van de Winkel.
The FDA recommends a 28 day dosage cycle for patients, which includes 200 mg on the first day of treatment, and 1000 mg one week later. 1,000 mg is then given to the patient on day one of the next 28 day dosage cycle, for a minimum of three, or a maximum of 12 cycles.