Arzerra (ofatumumab) PBS listed in Australia

Arzerra (ofatumumab) PBS listed in Australia

ARZERRA (ofatumumab) in combination with chlorambucil will be listed on the Pharmaceutical Benefits Scheme as of 01 Apr 2015 for patients with CLL who have not received prior therapy and are inappropriate for fludarabine-based therapy, GlaxoSmithKline has said.

pharmacydaily.com.au/news/a...

This news even made the National 7 News, which gave a good overview of CLL and included a brief interview with Dr Con Tam.

Neil

9 Replies

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  • Nice to see more choice for Australians!

    Interesting that the combination was not recommended in Canada for provincial funding. However Arzerra is Health Canada approved, for use. Funding would be by private insurance or patient payment.

    It further underlines that CLL is treated differently in different countries...

    pcodr.ca/idc/groups/pcodr/d...

    ~chris

  • Good to hear that, Neil. But it sounds very similar to Obinutuzumab (Gazyva) with Chlorambucil. Is there any way of knowing which people would respond better to which of those combinations?

    Paula

  • Paula, I guess that's a question best answered by a haematologist specialising in leukaemia treatments, but with a quick check online, I found that Fludarabine is contraindicated in patients who are hypersensitive to this drug or its components or if creatinine clearance is <30 ml/min.

    So it looks like this will best help patients with poor renal function or who react to the Fludarabine in FCR. At least these patients now have an effective alternative available to them.

    Considering there are other health conditions for which Arzerra has been shown to be effective and yet it was only approved for use with CLL patients, that's still a significant victory for Australian CLL patients.

    Neil

  • Ofatumumab also works in second and third lines in patients who are refractory to rituxan... basically low levels of CD20. It attaches to the Bcell in a different manner...

  • Thanks Neil and Chris. Apologies for my slow brain but I still don't see what's the difference between Ofatumumab and Obinutuzumab. They both seem to be useful for people who are refractory to Rituxan, and they seem to be very similar.

  • No they are different.. but similar! They both have the same target... CD20 they attach to the B cell and kill it in 3 ways... Some ways are stronger than others...

    However, they attach in different ways... and it is the attaching and different killing methods that seperates them.

    Basically, Rituxan and ofatumumab are Type 1 and Gazyva (obinutuzumab) is Type 2... it is more finely tuned...

    As Dr Sharman said, 'rituxan/ofatumumab is like thunder, but Obinutuzumab is like lightening....'

    Or think of rituxan as a six shooter, ofatumumab as a rifle and Gazyva (obinutuzumab) as a cannon...

  • Thanks Chris, that is very helpful. I will remember the thunder and lightning, and rifles and cannons. Sounds like Gazyva is much more powerful, but maybe with more collateral damage?

  • These are not chemo, the are higly targeted antibodies that attach only to B cells... the only colateral damage would be the fact they wipe out both good and malignant B cells...

    All the CD20 monoclonals have similar adverse events and the same target... ofatumumab attaches better and longer than Rituxan and gazyvaro, is better than both...

    Wiping out a part of the immune system, certainly has undesirable effects... but it is different than chemo...

    How fast the depleat CD20 I don't know...

    A good reference is the U.S. drug label website. Simply search on a drugs name, and it will find all relevant, clinic trial data etc... so you can compare adverse events, black box warnings etc. This website is updated frequently...

    dailymed.nlm.nih.gov/dailym...

  • Good news! Thanks for posting Neil

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