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.
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.
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:
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.
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 !
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.
Content on HealthUnlocked does not replace the relationship between you and doctors or other healthcare professionals nor the advice you receive from them.
Never delay seeking advice or dialling emergency services because of something that you have read on HealthUnlocked.
, I'm only surprised that they gave approval for plus Rituximab, especially with covid.Jackie
Five-year results for the iFCG regimen: first-line treatment of CLL patients with mutated IGHV and without del(17p)/TP53 mutation
