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FDA grants priority review to Arzerra for maintenance therapy in relapsed CLL

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The FDA granted priority review to a supplemental biologics license application that seeks approval of ofatumumab as a maintenance therapy for patients with relapsed chronic lymphocytic leukemia.

Ofatumumab (Arzerra; Genmab, Novartis), a human monoclonal antibody, targets the CD20 molecule found on the surface of CLL cells and normal B lymphocytes.

Last year, the FDA approved ofatumumab in combination with chlorambucil for patients with treatment-naive CLL who are not candidates for fludarabine-based therapy.

The supplemental application is based on results of the phase 3 PROLONG study, which assessed the safety and efficacy of ofatumumab maintenance therapy vs. no maintenance in patients with CLL who achieved partial or complete response to second- or third-line treatment.

“We are very pleased that the FDA has granted priority review for ofatumumab, which means ofatumumab could potentially be available as a maintenance therapy for patients suffering from relapsed CLL relatively soon,” Jan van de Winkel, PhD, CEO of Genmab, said in a press release. “We look forward to receiving FDA’s feedback on the application.”

The FDA is scheduled to make a decision by Jan. 21, 2016.