GAZYVA, a new anti-CD20 monoclonal antibody, is now Therapeutic Goods Administration (TGA) approved for the treatment of patients with previously untreated CLL in combination with Chlorambucil in Australia. It is NOT on the Pharmaceutical Benefits Scheme (PBS).
In the CLL11 GAZYVA study, GAZYVA + Chlorambucil:
* More than doubled Progression Free Survival (PFS) vs Chlorambucil alone (26.7 vs 11.1 months)
* Provided nearly 1-year improvement in PFS vs MabThera (Rituximab) + Chlorambucil (26.7 vs 15.2 months)
Danter, I've been advised by the Australian Leukaemia Foundation that Gazyva is a major submission to the July 2014 Pharmaceutical Benefits Advisory Committee (PBAC) meeting for consideration as a new listing for people with CLL.
Australian consumers have the opportunity to provide comments on new drug submissions, which for the July meeting must be submitted on line by next Wednesday the 11th of June.
As the PBAC site says:
"Your comments are welcome whether you are a patient, carer, member of the public, health professional or member of a consumer interest group."
Interesting photo, Neil. What are the grey blobs on the twigs, that look like clusters of dividing cells? Are they connected with the lichens, or something different?
Good to know that another treatment has been approved in Australia.
Danter, the Gazyva information came from the Australian Leukaemia Foundation, who were informed by Roche. I've passed on your excellent questions and will let you know if I hear any more.
Paula, what you can see are the seed pods or nuts on the Broombush, Broom Honeymyrtle or Brushwood shrub that was supporting the lichen. The shrubs are harvested and bundled together to form fencing panels. They create quite attractive fencing, which unfortunately has become a fire risk due to vandals poking fire starters into them and setting them alight.
Thank you danter. That makes at least two submissions. I found the submission process very easy to work through and I particularly liked the guidance text provided for each of the questions.
I've also posted to other CLL Forums about this opportunity, so lets hope that we do indeed get another available alternative for use for both front line and relapsed/refractory patients. Like you, I consider having an alternative treatment for patients that are running out of options as well as one that will work with poor genetics better than current options in Australia very important.
So now we have to wait...
Hopefully I'll be able to post about this being approved on the PBS before long!
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