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Published on 27 October 2009

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FDA approves leukaemia drug use

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The US Food and Drug Administration (FDA) has approved Arzerra (ofatumumab) for patients with chronic lymphocytic leukaemia (CLL) who do not respond to Campath or chemotherapy drug fludarabine

The drug, which is expected to be available shortly for prescription use, causes the body’s immune system to fight against normal and cancerous B-cells.

Hopes for its use in patients with non-Hodgkin’s lymphoma received a setback in August after a clinical trial found that it failed to help patients as much as expected.

The accelerated approval for CLL, after a positive recommendation from an FDA panel of experts in May, will trigger a welcome payment to Danish manufacturer Genmab from partner GlaxoSmithKline (GSK).

Said Genmab chief executive Lisa Drakeman: “The approval of Arzerra marks a key milestone for Genmab as it is our first antibody to reach the market.”

Meanwhile, GSK, the world’s second biggest drugmaker, is counting on the fact that Arzerra is showing promise for use with other diseases beyond CLL.

Copyright Press Association 2009

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