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Darzalex (daratumumab) approved in Canada

by Beacon Staff on Thu Jun 30, 2016 10:36 am

Dazalex (daratumumab) is now approved in Canada. Here is the press release from Janssen with information about the approval:

"Darzalex (Daratumumab) Approved By Health Canada As The First Human Anti-CD38 Monoclonal Antibody For The Treatment Of Multiple Myeloma" (June 30, 2016)

The approval is for the treatment of patients "who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immuno­modu­la­tory agent (IMiD), or who are refractory to both a PI and an IMiD."

The approval means that Darzalex can legally be administered to patients who fall within the approved patient population without the patients having to enroll in a clinical trial. The approval does not mean, however, that provincial health systems will immediately provide reim­burse­ment for the drug's use. That will require additional time.

Beacon Staff
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Re: Darzalex (daratumumab) approved in Canada

by Nancy Shamanna on Thu Jun 30, 2016 11:50 am

This is awesome news! To have the first monoclonal antibody approved by Health Canada is so encouraging. It has been on clinical trials here too. I am not sure, but I think that it can be used as a single agent, although many chemotherapies are combined with it, for example, Revlimid. Dexamethasone always seems to be included, though, and I wonder if that would also be used with Darzalex?

I think that Darzalex was 'fast tracked' this time with Health Canada.

Tomorrow is Canada Day, and this is sure a nice gift from the Government for myeloma patients.

Nancy Shamanna
Name: Nancy Shamanna
Who do you know with myeloma?: Self and others too
When were you/they diagnosed?: July 2009
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Re: Darzalex (daratumumab) approved in Canada

by Little Monkey on Thu Jun 30, 2016 1:52 pm

Yes, indeed. Happy Canada Day.

From what other members have said on the forum, I understand daratumumab (Darzalex) has little in the way of side effects.

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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Re: Darzalex (daratumumab) approved in Canada

by Maro on Fri Jul 01, 2016 2:27 am

Great news for Canada!

Best wishes to all

Maro
Who do you know with myeloma?: My mom
When were you/they diagnosed?: March 2014
Age at diagnosis: 63
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Re: Darzalex (daratumumab) approved in Canada

by KarenaD on Fri Jul 01, 2016 8:56 am

Wonderful news and Happy Canada Day to all my compatriots!

KarenaD
Name: Karen
Who do you know with myeloma?: Myself
When were you/they diagnosed?: November 4, 2015
Age at diagnosis: 54
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