Frontline Venetoclax/Obinutuzumab Approved in Europe for CLL

[AussieNeil]

In some welcome good news, "The European Commission has approved a fixed-dose combination of venetoclax (Venclexta) and obinutuzumab (Gazyva) for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL)"

onclive.com/web-exclusives/...

Neil

[seelel]

That's probably good news for Australia as well, because in time, we seem to follow once the US and Europe have approved a treatment.

[Ironj]

Little off topic but I would love to put a roof on that building.

[UK-Sparky]

Hopefully applies to UK as well

[camper2]

Oh that’s such good news for me (provided the UK follows suit) the numbers look good and it will avoid me having yet another round of chemo with C+O. I might be CLL ‘treatment naive’ but I have had 3 lots of chemo already. I have been told I am likely to be in treatment by the end of this year.

Because this Forum pushes us to see a CLL expert (thank you for that!) I have asked for a 2nd opinion on my treatment options at Barts (no appointment as yet) given my comorbidities and this post gives me ammunition to take to the discussion.

Thank you AussieNeil!

[t213jbl]

That is good news. Is there a link to the actual European Decision rather than press releases or external sites?

[AussieNeil Partner Administrator in reply to t213jbl]

"On 30 January 2020, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product venetoclax (Venclyxto).

:

Venclyxto in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). "

esmo.org/oncology-news/ema-...

[t213jbl]

Hi

Thanks

Yes I have seen that, and understand that it is a recommendation to change the terms etc. It is not confirmation of the EU decision made (I think) 9th March or thereabouts.

I will do some searching

[Etoile7]

This is EXCELLENT news...just too bad that rigj’y now with Covid is not the time I would start a treatment with 52% chances of neutropenia...