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# FDA Approves Genmab Supplemental BLA for Arzerra
- URL: https://www.fdaweb.com/fda-approves-genmab-supplemental-bla-for-arzerra/
- Published: 2016-08-31T12:00:00.000Z
- Updated: 2026-09-14T21:28:42.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5136673

FDA has approved a Genmab supplemental BLA for the use of Arzerra (ofatumumab) in combination with fludarabine and cyclophosphamide (FC) for treating patients with relapsed chronic lymphocytic leukemia (CLL). The submission, which was given a priority review in May, was submitted by Novartis under a collaboration between the two companies. Approval was based on results from the Phase 3 COMPLEMENT 2 study that evaluated ofatumumab in combination with FC versus FC alone in patients with relapsed CLL. The study met the primary endpoint, the company says, with a median progression free survival in patients receiving ofatumumab in combination with FC of 28.9 months, compared to 18.8 months in patients receiving FC alone.