US regulator ponders Arzerra
pharmafile | October 22, 2013 | News story | Sales and Marketing | Arzerra, CLL, FDA, GSK
GlaxoSmithKline and Genmab have submitted their blood cancer drug Arzerra to the FDA as a first-line treatment for chronic lymphocytic leukaemia (CLL).
Earlier this month, the companies made a similar submission to European authorities.
They want Arzerra (ofatumumab) that was licensed by GSK three years ago in a $2.1 billion deal, to be used in combination with an alkylator-based therapy for treatment-naïve CLL patients who are inappropriate for fludarabine-based therapy.
At present it cannot be used anywhere in the world in patients who have not already received treatment for CLL – so to be shown the green light as a first-line therapy would be a huge boost to sales of Arzerra, which stood at $100 million in 2012.
All the submissions are primarily based on a Phase III study which saw the drug used in combination with chlorambucil – against chlorambucil alone – in more than 400 patients with previously untreated CLL.
Headline results were announced in May and full data will be presented at the 2013 American Society of Hematology Annual Meeting in December.
GSK and Genmab have already been granted ‘breakthrough therapy’ designation for Arzerra by the FDA in this setting: CLL is the most common form of leukaemia in adults, with 11,000 new cases in Europe and 15,600 in the US each year.
The human monoclonal antibody targets an epitope on the CD20 molecule encompassing parts of the small and large extracellular loops – but even if Arzerra is approved in the new setting, the manufacturers will not have things all their own way.
Napp’s CLL drug Levact (bendamustine) and Roche’s MabThera (rituximab) – sold as Rituxan in the US – are not going to give up their own positions in this therapy area.
MabThera, which has a licence for CLL, as well as for rheumatoid arthritis and non-Hodgkin’s lymphoma, made nearly $7 billion last year.
Adam Hill
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