Some good news for the Canadian multiple myeloma community. Health Canada has accepted for review the application to have daratumumab (Darzalex) approved as a new myeloma therapy in Canada.
Here is a press release announcing the news:
"Janssen's New Drug Submission For Daratumumab For Treatment Of Multiple Myeloma Accepted For Review By Health Canada", Janssen press release, issued Nov 18, 2015.
The application appears to be based on data similar to what has been submitted to U.S. and European authorities in the applications for Darzalex's approval in those parts of the world.
As most of you (all of you?) probably know by now, Darzalex was approved earlier this week in the U.S. Here is the Beacon news article on that approval:
"Darzalex (Daratumumab) Approved By FDA For Multiple Myeloma", The Myeloma Beacon, Nov 17, 2015.
Forums
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Re: Daratumumab (Darzalex) submitted for review in Canada
Thank you Beacon Staff, for this AWESOME news about Darzalex being reviewed by Health Canada. Quite often it seems that we have to wait here for quite a while after the US approval and the EU one also, for a new myeloma drug. I hope that HC looks favourably on it, and then it can be reviewed by CADTH and ultimately by the provinces. I wonder if there would be clinical trials for it running in the interim?
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Nancy Shamanna - Name: Nancy Shamanna
- Who do you know with myeloma?: Self and others too
- When were you/they diagnosed?: July 2009
Re: Daratumumab (Darzalex) submitted for review in Canada
W00T! Go Team Canada!
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LisaE - Name: Lisa
- Who do you know with myeloma?: Husband
- When were you/they diagnosed?: April 2014
- Age at diagnosis: 67
Re: Daratumumab (Darzalex) submitted for review in Canada
I am so glad to see this news!
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cdnirene - Name: Irene S
- Who do you know with myeloma?: me
- When were you/they diagnosed?: September 2014
- Age at diagnosis: 66
Re: Daratumumab (Darzalex) submitted for review in Canada
This is great news; hopefully the Ontario Government will cover it, is it by injection or pills ?
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Little Monkey - Name: Little Monkey
- Who do you know with myeloma?: Father-stage 1 multiple myeloma
- When were you/they diagnosed?: March/April of 2015
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Multibilly - Name: Multibilly
- Who do you know with myeloma?: Me
- When were you/they diagnosed?: Smoldering, Nov, 2012
Re: Daratumumab (Darzalex) submitted for review in Canada
Thanks Billy,
If the Ontario Government approves coverage, the fact it is given by IV means it will be given in hospital. Therefore, the hospitals bill the government directly and there is no need to put it through private pharma insurance if you have it (or Trillium Plan if you don't have private insurance).
If the Ontario Government approves coverage, the fact it is given by IV means it will be given in hospital. Therefore, the hospitals bill the government directly and there is no need to put it through private pharma insurance if you have it (or Trillium Plan if you don't have private insurance).
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Little Monkey - Name: Little Monkey
- Who do you know with myeloma?: Father-stage 1 multiple myeloma
- When were you/they diagnosed?: March/April of 2015
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