FDA approves immunotherapy for chronic lymphocytic leukemia (CLL)

The U.S. Food and Drug Administration has approved GlaxoSmithKline's monoclonal antibody ofatumumab (to be marketed as Arzerra) for the treatment of chronic lymphocytic leukemia (CLL) in patients whose cancer is considered relapsed or refractory.

The FDA approved ofatumumab under its accelerated approval process.

“The approval of Arzerra illustrates FDA's commitment to using the accelerated approval process to approve drugs for patients who have limited therapeutic options,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research.

Side effects or adverse events associated with ofatumumab include increased risk of developing progressive multifocal leukoencephalopathy (PML), a brain infection that is generally fatal. This makes Arzerra at least the second monoclonal antibody with potential links to PML, the other being the widely used Rituxan (rituximab).

Those patients considered at high risk for Hepatitis B should be screened before being treated with ofatumumab. Patients with evidence of inactive hepatitis should be monitored for re-activation of the infection during and after completing treatment.

The question is whether this extends to small lymphocytic lymphoma (SLL), as even the World Health Organization considers CLL and SLL to be the same disease.

Ofatumumab is in trials to test its efficacy in treating both follicular lymphoma and diffuse large b-cell lymphoma.

Source: FDA press release