EMA gets first line Arzerra submission
pharmafile | October 7, 2013 | News story | Sales and Marketing |Â Â Arzerra, GSK, Genmab, blood cancerÂ
GlaxoSmithKline and Genmab have submitted their blood cancer drug Arzerra to the European Medicines Agency (EMA) in a first line setting.
At present Arzerra (ofatumumab) is not approved or licensed anywhere in the world for use in patients who have not already received treatment for chronic lymphocytic leukaemia (CLL).
The companies have now asked the European regulator to look at Arzerra in combination with an alkylator-based therapy for CLL patients who have not been treated before and who cannot have fludarabine-based therapy.
This follows a similar move in the US, where GSK and Genmab were granted ‘breakthrough therapy’ designation for Arzerra by the FDA in this setting in August.
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.
Full data has been submitted for presentation at the 2013 American Society of Hematology Annual Meeting in December.
To gain approval in the US and Europe as a first line therapy would lead to a greater uptake of the drug, which targets an epitope on the CD20 molecule and made $100 million in sales last year.
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 – but the companies will face stiff competition even if Arzerra is approved.
Napp’s CLL drug Levact (bendamustine) and Roche’s big-selling MabThera (rituximab) – sold as Rituxan in the US would both be key rivals in this space.
MabThera, which has a licence for CLL, as well as for rheumatoid arthritis and non-Hodgkin’s lymphoma, made nearly $7 billion in 2013.
GSK licensed Arzerra with Genmab three years ago in a deal worth $2.1 billion.
Genmab was founded in 1999 and the brand, its first marketed antibody, is currently approved to treat CLL in patients who are refractory to fludarabine and alemtuzumab.
Adam Hill
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