GSK’s Arzerra conditionally approved in Europe
pharmafile | April 20, 2010 | News story | Research and Development, Sales and Marketing | Arzerra, GSK, leukaemia
GlaxoSmithKline’s orphan cancer treatment Arzerra has been given conditional marketing authorisation in the European Union.
Arzerra (ofatumumab) can be used in patients with refractory chronic lymphocytic leukaemia (CLL), who have not responded to standard therapies fludarabine and alemtuzumab.
Its authorisation is conditional because regulatory advisors the CHMP decided the benefit of immediate availability outweighed the fact that additional data was still required.
“It is a positive risk-benefit analysis,” a GSK spokesperson said. “The CHMP believe it fulfills an unmet medical need.”
She added that GSK will now be required to carry out an open-label multi-centre study on Arzerra’s safety and efficacy versus a physician’s choice of drug; and a phase IV observational study of Arzerra.
There is no timescale for this data to be produced, although Arzerra’s conditional authorisation is subject to an annual review and a pharmacovigilance plan will also be implemented.
Trials showed a high response rate to the disease in patients refractory to both fludarabine and alemtuzumab, with the most common side effects infections and infusion reactions.
But the CHMP said it should be prescribed by experienced cancer physicians in an environment where full resuscitation facilities are immediately available.
Arzerra is a monoclonal antibody medicinal product targeting CD20, a cell surface marker of B lymphocytes, and was designated an orphan medicinal product in November 2008.
In March, NICE recommended Roche’s MabThera (rituximab), used with fludarabine and cyclophosphamide, to treat patients with relapsed or refractory CLL.
It was not deemed cost-effective in patients whose condition has not previously responded to fludarabine or has relapsed within six months of treatment, or has previously been treated with MabThera.
CLL is the most common form of adult leukaemia and accounts for around 30-40% of leukaemia cases in Western countries and is currently incurable.
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