Forums
Re: Canada & multiple myeloma
The Province of Saskatchewan has now extended occupational health and safety coverage for multiple myeloma to volunteer firefighters.
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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: Canada & multiple myeloma
Darzalex (daratumumab) is now funded in New Brunswick. It can be used in combination with bortezomib plus dexamethasone or dexamethasone alone for relapsed/refrectory patients.
Kyprolis (carfilzomib) is now funded in New Brunswick. It can be used in combination with dexamethasone for relapsed patients.
Kyprolis (carfilzomib) is now funded in New Brunswick. It can be used in combination with dexamethasone for relapsed patients.
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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: Canada & multiple myeloma
Saskatchewan, as of July 15, is now funding Darzalex (daratumumab). It is to be used with Revlimid plus dexamethasone or with bortezomib (Velcade) plus dexamethasone in patients who have had 1 prior therapy.
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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: Canada & multiple myeloma
The triplet Pomalyst (pomalidomide, Imnovid) plus bortezomib (Velcade) and dexamethasone has been approved by Health Canada as of July 10 (related press release). This triplet is approved for use in patients who have had at least 1 prior line of therapy including Revlimid (lenalidomide). The combination is not yet funded, however, by provincial government health plans.
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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: Canada & multiple myeloma
The Canadian Agency for Drugs and Technologies in Health (CADTH) has recommended the reimbursement for Pomalyst (pomalidomide) in combination with dexamethasone and bortezomib (Velcade) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior treatment regimen including Revlimid (lenalidomide).
Also, as of Aug 16, 2019, Darzalex has been approved in Newfoundland, in combination with Revlimid and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma with good performance status who have received at least one prior therapy.
Also, as of Aug 16, 2019, Darzalex has been approved in Newfoundland, in combination with Revlimid and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma with good performance status who have received at least one prior therapy.
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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: Canada & multiple myeloma
Health Canada has approved the combination of Darzalex, Revlimid (lenalidomide), and dexamethasone for the treatment of newly diagnosed, transplant-ineligible multiple myeloma. The decision by the Canadian regulatory authority was announced this morning in this press release issued by Janssen, the company that markets Darzalex in Canada and the rest of the world.
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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: Canada & multiple myeloma
Sarclisa in combination with Pomalyst and dexamethasone is now approved and available in Canada as a treatment option for relapsed / refractory multiple myeloma:
"Sarclisa (Isatuximab For Injection) Now Available In Canada For Patients With Relapsed And Refractory Multiple Myeloma," Sanofi Canada press release, July 8, 2020.
"Sarclisa (Isatuximab For Injection) Now Available In Canada For Patients With Relapsed And Refractory Multiple Myeloma," Sanofi Canada press release, July 8, 2020.
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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: Canada & multiple myeloma
Health Canada has approved subcutaneous Darzalex, or "Darzalex SC" as it will be known in Canada (it's called Darzalex Faspro in the U.S.):
"Janssen Announces Health Canada Approval Of Darzalex SC, A New Subcutaneous Formulation For The Treatment Of Patients With Multiple Myeloma," press release, Janssen Inc., August 4, 2020.
Excerpt:
"Health Canada has approved Darzalex SC (daratumumab), a new subcutaneous formulation of daratumumab. Darzalex SC is approved in four regimens across five indications in patients with multiple myeloma, most notably newly diagnosed, transplant-ineligible patients as well as relapsed or refractory patients. As a fixed-dose formulation, Darzalex SC can be administered over approximately three to five minutes, significantly less time than intravenous (IV) Darzalex, which is administered over hours. Darzalex SC is the only subcutaneous CD38-directed antibody approved in the treatment of multiple myeloma.
In the Phase 3 COLUMBA study published in The Lancet, Darzalex SC demonstrated a consistent overall response rate (ORR) and pharmacokinetics and a similar safety profile compared with IV Darzalex in patients with relapsed or refractory multiple myeloma. In addition, there was a nearly two-thirds reduction in systemic administration-related reactions (ARRs) for Darzalex SC compared to IV Darzalex (13 per cent vs. 34 per cent, respectively)."
"Janssen Announces Health Canada Approval Of Darzalex SC, A New Subcutaneous Formulation For The Treatment Of Patients With Multiple Myeloma," press release, Janssen Inc., August 4, 2020.
Excerpt:
"Health Canada has approved Darzalex SC (daratumumab), a new subcutaneous formulation of daratumumab. Darzalex SC is approved in four regimens across five indications in patients with multiple myeloma, most notably newly diagnosed, transplant-ineligible patients as well as relapsed or refractory patients. As a fixed-dose formulation, Darzalex SC can be administered over approximately three to five minutes, significantly less time than intravenous (IV) Darzalex, which is administered over hours. Darzalex SC is the only subcutaneous CD38-directed antibody approved in the treatment of multiple myeloma.
In the Phase 3 COLUMBA study published in The Lancet, Darzalex SC demonstrated a consistent overall response rate (ORR) and pharmacokinetics and a similar safety profile compared with IV Darzalex in patients with relapsed or refractory multiple myeloma. In addition, there was a nearly two-thirds reduction in systemic administration-related reactions (ARRs) for Darzalex SC compared to IV Darzalex (13 per cent vs. 34 per cent, respectively)."
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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