GAZYVA® (Obinutuzumab) gains TGA approval for 1st line treatment of CLL in combination with Chlorambucil in Australia

[AussieNeil]

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)

This follows FDA approval 7 months ago:

healthunlocked.com/cllsuppo....

healthunlocked.com/cllsuppo...

Neil

Picture shows some lichen on a native shrub

[danter]

Neil,

Good news for us Aussies.

It prompts a couple of questions in my mind however which may not have any answers at this time of course......

- You say it's not on the PBS. Is this likely to happen anytime soon?

- Also is it likely to be extended to previously treated patients as well?

[AussieNeil Partner Administrator in reply to danter]

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."

health.gov.au/internet/main...

On line submission:

health.gov.au/internet/main...

On this page you will see the agenda for the meeting and you will see Gazyva (listed under Obinutuzumab)

pbs.gov.au/info/industry/li...

I'll be making a submission. I hope that you and other interested Aussies can do the same.

Thanks,

Neil

[PaulaS Volunteer]

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.

[AussieNeil Partner Administrator]

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.

Info on Broombush:

en.wikipedia.org/wiki/Melal...

More info including photo of flowering plant with seed pods

bie.ala.org.au/species/Broo...

Neil

[danter in reply to AussieNeil]

Thanks a lot for this info Neil.

I'll put something together as you've suggested and submit it.

If you do hear anymore, I'll obviously be very interested to hear it.

Meanwhile I'll keep my eyes peeled too.

[AussieNeil Partner Administrator]

How to submit your comments supporting PBS listing of GAZYVA for Australian CLL patients:

healthunlocked.com/cllsuppo...

[danter in reply to AussieNeil]

Submitted my comments today Neil.....I sincerely hope they're seriously considered along with all the other inputs!

I included some comments re the use of Gazyva for previously treated patients who have relapsed as well as for front-line treatment.

keep fingers crossed eh?

[AussieNeil Partner Administrator in reply to danter]

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!

Neil

[danter in reply to AussieNeil]

Neil,

Thanks for your initiatives in this matter. Like you, I hope we see a successful outcome in the near future.