Arzerra (ofatumumab) PBS listed in Australia - CLL Support

CLL Support

23,337 members40,044 posts

Arzerra (ofatumumab) PBS listed in Australia

AussieNeil profile image
AussieNeilPartnerAdministrator
9 Replies

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

Written by
AussieNeil profile image
AussieNeil
Partner
To view profiles and participate in discussions please or .
Read more about...
9 Replies
Cllcanada profile image
CllcanadaTop Poster CURE Hero

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

PaulaS profile image
PaulaSVolunteer

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

AussieNeil profile image
AussieNeilPartnerAdministrator in reply toPaulaS

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

Cllcanada profile image
CllcanadaTop Poster CURE Hero in reply toAussieNeil

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...

PaulaS profile image
PaulaSVolunteer in reply toCllcanada

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.

Cllcanada profile image
CllcanadaTop Poster CURE Hero in reply toPaulaS

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...

PaulaS profile image
PaulaSVolunteer in reply toCllcanada

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?

Cllcanada profile image
CllcanadaTop Poster CURE Hero in reply toPaulaS

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...

DebinOzinLondon profile image
DebinOzinLondon

Good news! Thanks for posting Neil

Not what you're looking for?

You may also like...

Arzerra(R) (Ofatumumab) granted FDA 'Breakthrough Therapy Designation' for Previously Untreated CLL

Genmab A/S and GlaxoSmithKline plc (GSK) announced that the US Food and Drug Administration (FDA)...
Cllcanada profile image
Top Poster CURE Hero

Duvelisib Dosing Modification Does Not Compromise Efficacy in Heavily Pretreated CLL/SLL

Reducing or interrupting duvelisib (Copiktra) treatment does not increase toxicity or reduce...
Jm954 profile image
Administrator

Venetoclax has been added to the Pharmaceutical Benefits Scheme in Australia for use as a retreatment for CLL/SLL

In more good news, today the Pharmaceutical Benefits Scheme (PBS) in Australia added venetoclax to...
CLLerinOz profile image
Administrator

Venetoclax Added to Ibrutinib in High-Risk CLL Achieves a High Rate of Undetectable Minimal Residual Disease.

December 8, 2019 ASH poster. There are lots of us on long term Ibrutinib who have had a good...
Jm954 profile image
Administrator

"Accelerated" chronic lymphocytic leukemia/small lymphocytic lymphoma: unraveling CLL/SLL biological gray zone in the era of novel therapies

Encouraging news in this abstract from CLL/SLL researchers at the Northwestern Memorial Hospital,...
AussieNeil profile image
Partner