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Association details:
Evidence:
Evidence Level:
Sensitive: A1 - Approval
Source:
Published date:
03/31/2021
Excerpt:
SARCLISA is a CD38-directed cytolytic antibody indicated:...in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor.
Evidence Level:
Sensitive: A1 - Approval
Title:

isatuximab (Sarclisa) is accepted for restricted use within NHSScotland

Published date:
03/05/2021
Excerpt:
isatuximab (Sarclisa) is accepted for restricted use within NHSScotland....in combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor (PI) and have demonstrated disease progression on the last therapy.
Evidence Level:
Sensitive: A2 - Guideline
Source:
Title:

Isatuximab with pomalidomide and dexamethasone for treating relapsed and refractory multiple myeloma

Published date:
10/17/2020
Excerpt:
Isatuximab, plus pomalidomide and dexamethasone, is recommended for use within the Cancer Drugs Fund as an option for treating relapsed and refractory multiple myeloma.
Evidence Level:
Sensitive: A2 - Guideline
New
Source:
Excerpt:
The NCCN Panel has included Isatuximabirfc/pomalidomide/dexamethasone as a category 1, preferred option for the treatment of patients with relapsed/refractory MM...Multiple Myeloma: Preferred Regimens...Therapy for previously treated multiple myeloma...Isatuximab-irfc/pomalidomide/dexamethasone (category 1)
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

Isatuximab plus pomalidomide and dexamethasone in relapsed/refractory multiple myeloma patients with renal impairment: ICARIA-MM subgroup analysis

Published date:
05/23/2020
Excerpt:
The randomized, phase 3 ICARIA-MM study investigated isatuximab (Isa) with pomalidomide and dexamethasone (Pd) versus Pd in patients with relapsed/refractory multiple myeloma...Median progression-free survival (PFS) for patients with RI was 9.5 months with Isa-Pd (n = 55) and 3.7 months with Pd (n = 49; hazard ratio [HR] 0.50; 95% confidence interval [CI], 0.30–0.85)....The overall response rate (ORR) with and without RI was higher with Isa-Pd (56 and 68%) than Pd (25 and 43%)....In summary, the addition of Isa to Pd improved PFS, ORR and renal response rates.
DOI:
10.1038/s41375-020-0868-z
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Title:

Sanofi receives positive CHMP opinion for Sarclisa (isatuximab) for the treatment of relapsed and refractory multiple myeloma

Published date:
03/27/2020
Excerpt:
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Sarclisa (isatuximab). The CHMP recommends Sarclisa in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adult patients with relapsed and refractory multiple myeloma (MM)...The CHMP positive opinion is based on data from ICARIA-MM, the first randomized Phase 3 trial to evaluate an anti-CD38 monoclonal antibody (mAB) in combination with pom-dex.