CHMP recommends variation of approval for Arzerra in CLL - GSK

The EMA's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending a variation to the terms of the marketing authorization for Arzerra (ofatumumab), from Glaxo Smith Kline, for a new indication in combination with chlorambucil or bendamustine for the treatment of patients with Chronic Lymphocytic Leukemia (CLL) who have not received prior therapy and who are not eligible for fludarabine-based therapy.

The application is based on results from Phase III OMB110911 study (COMPLEMENT 1), a randomised, open-label, parallel-arm, multicentre, pivotal Phase III study evaluating the combination of ofatumumab and chlorambucil versus chlorambucil alone, and the Phase II OMB115991, a single-arm, multicentre study that evaluated the efficacy of ofatumumab in combination with bendamustine. The FDA approved this indication in April.