Genmab A/S and GlaxoSmithKline plc (GSK) announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for Arzerra(r) (ofatumumab) in combination with chlorambucil for the treatment of patients with chronic lymphocytic leukemia (CLL) who have not received prior treatment and are inappropriate for fludarabine-based therapy.
Ofatumumab is not approved or licensed anywhere in the world for use in this treatment setting.
Breakthrough Therapy designation is the newest of the FDA's programs aimed at accelerating the development and review times of drugs for serious or life-threatening conditions.
I may have got it wrong, Sparkler, but I think it's only been approved in the US, not Canada. We'll have to find someone else's lawn to camp on. (Just joking!)
It was approved by FDA in Oct 2009 for chronic lymphocytic leukemia that is refractory to fludarabine and alemtuzumab. It was conditionally approved by the EMA for refractory chronic lymphocytic leukemia in 2010.
This new designation is for first line combined with chlorambucil .
Ofatumumab is not available in Canada for CLL. ;-(
Interesting as that combination is still part of the Rialto trial worldwide, which I thoought didn't finish until 2017. I'm on the other arm of the trial ie with Bendamustine rather than Chlorambucil.
Primary outcome of the RialtO trial is progression free survival, PFS, they must have enough data to move forward with approval... secondary outcomes will last until 2017 like overall survival etc.
Breakthrough designation is the first step of a long process that could take a year or more, then new drug application, and beginning the approval process.
RialtO is a U.K. only trial from my understanding.
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