GSK-Genmab blood cancer drug approved in US
pharmafile | November 2, 2009 | News story | Research and Development, Sales and Marketing | Arzerra
GlaxoSmithKline and Philadelphia-based Genmab have received accelerated US approval for their blood cancer drug Arzerra.
It is to be used in chronic lymphocytic leukemia (CLL) patients who do not respond to standard treatments fludarabine and alemtuzumab, the active ingredient in Genzyme's Campath.
The US Food and Drug Administration based its decision on a study in which 42% of patients with CLL, which was refractory to both of these, responded to Arzerra (ofatumumab).
The median duration of response was 6.5 months and the drug is expected to be available for prescription use in the next few weeks.
Arzerra's rivals in this therapy area include Roche's MabThera/Rituxan.
Genmab chief executive Lisa Drakeman said the company was pleased to have moved the product "so quickly through research and development".
The move had been expected, given the positive recommendation it received from the FDA's Oncologic Drugs Advisory Committee in May.
"Patients now have a new choice," said Kathy Rouan, GSK medicines development leader. "Arzerra is a significant step forward in helping patients and physicians better manage the challenges of refractory CLL."
One of four main types of leukemia, CLL is the most common adult form of the disease.
The Leukemia and Lymphoma Society estimates that more than 15,000 new cases of CLL will be diagnosed this year and says that more than 85,000 people in the US either have it or are in remission from CLL.
Arzerra is the first antibody Genmab, whose focus is on developing fully human antibody therapeutics for cancer sufferers, has brought to market.
It works by attaching to loop epitopes on a molecule called CD20, found on the surface of B-cells – the cells which become cancerous in 95% of CLL cases.
In the other 5%, the cell that transforms from normal to leukemic has the features of a T lymphocyte or an NK cell.
The most common serious adverse reactions in the trial were pneumonia, sepsis, neutropenia, and pyrexia.
GSK has put Arzerra into its patient assistance programme, which is designed to help cancer sufferers pay for medicines.
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