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Marketing authorisation application submitted to the European Medicines Agency for the use of ofatumumab for first line treatment

Marketing authorisation application submitted to the European Medicines Agency for the use of ofatumumab for first line treatment

GlaxoSmithKline plc and Genmab A/S have submitted a variation to the marketing authorisation application (MAA) to the European Medicines Agency (EMA) for the use of Arzerra (ofatumumab) in combination with an alkylator-based therapy, to be used for treatment of Chronic Lymphocytic Leukaemia (CLL) patients who have not received prior treatment and are inappropriate for fludarabine-based therapy (my emphasis- Neil).

The submission is based primarily on results from an international, multi-centre, randomised phase III study of ofatumumab in combination with chlorambucil versus chlorambucil alone in more than 400 patients with previously untreated CLL.

pharmabiz.com/NewsDetails.a...

Good to know that an alternative treatment may be available for those where fludarabine is inappropriate.

Neil

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Followed by....

PRESS RELEASE October 18, 2013

GSK and Genmab Announce Submission to US Regulatory Authorities for Arzerra(R) (Ofatumumab) as 1st Line Treatment of Chronic Lymphocytic Leukemia (CLL)

online.wsj.com/article/PR-C...

Reply

Neil,

It looks like the big phamacitical companies are now confident about one of many new drugs & treatments - as you say good news & watch this space !

Marty

Reply

Patent is coming off rituxan... GSK is eyeing the 7 billion dollar a year market... ofatumumab has always been second fiddle, now rituxan may have some competition.

Watch for announcements of rituxan Biosimilars as well, many companies are waiting in the wings... for a slice of the pie... Sandoz and AstraZeneca appear to be on track as well as the Indian drug companies, Natco and Dr Reddys already have rituxan bios, Teva and Samsung have fallen by the wayside...

It will be interesting to see the role of Roche's new obinutuzumab ...

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