Health Canada approves Ibrutinib plus Rituxima... - CLL Support

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Health Canada approves Ibrutinib plus Rituximab for First Line Treatment of Patients with Chronic Lymphocytic Leukemia (CLL)

AussieNeil profile image
AussieNeilAdministrator

Good News for our untreated Canadian members!

This latest approval is based on the Phase 3 ECOG1912 study (also referred to as E1912) that demonstrated newly diagnosed patients age 70 or younger (median age of 58) treated with IMBRUVICA® plus rituximab had significantly improved progression-free survival (PFS) compared to patients treated with fludarabine, cyclophosphamide and rituximab (FCR). The risk of disease progression or death was reduced by 66 per cent in the IMBRUVICA® arm compared with FCR, with a median follow-up time of 37 months.

newswire.ca/news-releases/h...

Now it's just a matter of waiting for provincial funding...

Neil

12 Replies

Hi Neil,

That's really good news, I can see Chris is looking down smiling.

Can I ask what the Canadian situation is with ABT199 and new patients.

Best wishes,

Ernest

AussieNeil profile image
AussieNeilAdministrator in reply to Ernest2

Venetoclax in combination with Obinutuzumab was approved for first line treatment of CLL by Health Canada in May of last year:

healthunlocked.com/cllsuppo...

All that Canadian advocacy work is paying dividends! Chris would be proud!

Neil

Hi Neil good news for Australia. I was told by my haematologist that the U.K. was going for Venetoclax and Obinutuzumab over Ibrutinib. I see that was first approved in Australia before ibrutinib and rituximab. Hopefully we are going to follow suit here in the U.K.I am on the flair trial here in the U.K. ibrutinib and rituximab arm. I was told rituximab added nothing to the Ibrutinib alone so I am surprised and pleased to hear it is still being added in Australia.

Stay safe

Ann

Thanks for sharing Neil. That's great news! 🇨🇦

Jm954 profile image
Jm954Administrator

Good news :) , I'm only surprised that they gave approval for plus Rituximab, especially with covid.Jackie

AussieNeil profile image
AussieNeilAdministrator

Here is a report on the early benefit assessment by the German Institute for Quality and Efficiency in Health Care (IQWiG), per the phase 3 ECOG1912 study, which led to the Health Canada approval:

eurekalert.org/pub_releases...

Great news 🎉

Great but with covid this won’t be approved anytime Soon. It’s been 8 months since health Canada approved the obinituzimab and venetoclax and no provincial funding unfortunately, as the government sees helping business before cancer patients

Thank you Neil. This is good news, but our Provinces usually take a long time to set any new treatment in motion unfortunately.Being approved by feds makes it possible to get it out of the label, if you are lucky to have a good doctor.

Dana

Hi. I'm confused by newly diagnosed part.. is this for individuals in watch and wait then or for once you need treatment?Thank you for the all you do for us !

AussieNeil profile image
AussieNeilAdministrator in reply to Rosiehiker

Well spotted. As you have observed, the quoted text is misleading. The referenced clinical trial states in the Elegibility Criteria:

Has met at least one of the following indications for treatment:

- Evidence of progressive marrow failure as manifested by the development of worsening anemia (hemoglobin [Hg] < 11 g/dl) and/or thrombocytopenia (platelets < 100 x 10^9/L)

- Symptomatic or progressive lymphadenopathy, splenomegaly, or hepatomegaly

and so on, per the usual reasons for ending Watch and Wait to start treatment.

See: clinicaltrials.gov/ct2/show...

Neil

Thank you! I always hold out this hope that something could be developed that actually could be used in watch and wait.. this is still good news!

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