PHILADELPHIA -- October 27, 2009 -- The US Food and Drug Administration (FDA) has granted accelerated approval of ofatumumab (Arzerra) for use in patients with chronic lymphocytic leukaemia (CLL) refractory to fludarabine and alemtuzumab.
The approval is based on results from a pivotal study in which 42% of patients with CLL who were refractory to both fludarabine and alemtuzumab responded to treatment with ofatumumab. These patients had a median duration of response of 6.5 months. The most common adverse reactions (>=10%) seen were neutropenia, pneumonia, pyrexia, cough, diarrhoea, anaemia, fatigue, dyspnoea, rash, nausea, bronchitis, and upper respiratory tract infections. The most common serious adverse reactions seen were infections (including pneumonia and sepsis), neutropenia, and pyrexia.
Ofatumumab, which is expected to be available for prescription in the coming weeks, is a monoclonal antibody that causes the body's immune response to fight against normal and cancerous B cells. Ofatumumab attaches to the small and large loop epitopes on CD20, which is found on the surface of B cells.
The approval of ofatumumab was supported by a positive recommendation by the FDA's Oncologic Drugs Advisory Committee at the 45th Annual Meeting of the American Society of Clinical Oncology on May 29, 2009, in which the panel voted 10-3 that the data for ofatumumab were likely to predict clinical benefit for patients with CLL whose disease is refractory to fludarabine and alemtuzumab.
GSK has added ofatumumab to its patient assistance program, Commitment to Access, and has expanded the program. This program assists eligible patients, with or without insurance, with paying for cancer medicines. For more information about the program, visit www.CommitmentToAccess.com or call 1-8ONCOLOGY1 (1-866-265-6491).
SOURCE: GlaxoSmithKline
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