Articles tagged with: Isatuximab
Press Releases»
- First and only anti-CD38 antibody in combination with pomalidomide and dexamethasone (pom-dex) to be approved in Canada1,2
- SARCLISA™ in combination with pom-dex significantly reduced the risk of disease progression or death by 40% compared to pom-dex alone in a pivotal trial2
- Multiple myeloma is the third most common blood cancer in Canada3
Mississauga, ON (Press Release) – Sanofi Canada is pleased to announce that Health Canada has approved SARCLISA™ in combination with pomalidomide and dexamethasone for the treatment of adults with relapsed and refractory multiple myeloma (RRMM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.2
"Immunotherapies like SARCLISA™ leverage the immune system to fight multiple myeloma and we're seeing real progress in their ability to help patients. This was not the case over a decade ago," says Dr. …
Press Releases»
- EC approval based on data from first randomized Phase 3 trial (ICARIA-MM) to report results evaluating an anti-CD38 monoclonal antibody combined with pomalidomide and dexamethasone (pom-dex)
- Sarclisa in combination with pom-dex significantly reduced the risk of progression or death by 40% versus pom-dex alone
- Multiple myeloma is the second most common blood cancer, with approximately 40,000 new cases per year in Europe
Paris, France (Press Release) – The European Commission (EC) has approved Sarclisa® (isatuximab) in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adult patients with relapsed and refractory multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy.
Sarclisa is a monoclonal antibody (mAb) that binds to a specific epitope on the CD38 receptor of MM cells.
“The EC approval of …
Press Releases»
- IKEMA trial results released early based on recommendation of an Independent Data Monitoring Committee
- Addition of Sarclisa significantly reduced the risk of disease progression or death compared to carfilzomib and dexamethasone alone
- Results will be submitted to an upcoming medical meeting and form the basis for regulatory submissions later this year
Paris, France (Press Release) – The Phase 3 IKEMA clinical trial evaluating Sarclisa® (isatuximab) added to carfilzomib and dexamethasone met the primary endpoint at its first planned interim analysis, demonstrating significantly prolonged progression-free survival compared to standard of care carfilzomib and dexamethasone alone in patients with relapsed multiple myeloma. There were no new safety signals identified in this study.
“When Sarclisa was added to standard-of-care treatment carfilzomib and dexamethasone in this phase 3 trial, results clearly demonstrated a significant reduction in …
Press Releases»
- Positive CHMP opinion based on data from ICARIA-MM, the first randomized Phase 3 trial to evaluate an anti-CD38 in combination with pom-dex
- Sarclisa in combination with pomalidomide and dexamethasone (pom-dex) significantly reduced the risk of disease progression or death in adults by 40% compared to pom-dex alone in the trial
- Sarclisa was approved by the FDA on March 2 in combination with pom-dex for the treatment of certain adults with RRMM
- Multiple myeloma remains an incurable cancer associated with significant patient burden and need for additional treatments
Paris, France (Press Release) – 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) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy.
The European Commission …
Press Releases»
- Sarclisa in combination with pomalidomide and dexamethasone (pom-dex) significantly reduced the risk of disease progression or death by 40% compared to pom-dex alone in a pivotal trial
- FDA approval based on data from the only randomized Phase 3 trial (ICARIA-MM) to evaluate an anti-CD38 in combination with pom-dex that has presented results to date
- Multiple myeloma is the second most common blood cancer, affecting more than 130,000 patients in the U.S.; approximately 32,000 Americans are diagnosed with multiple myeloma each year
Bridgewater, NJ (Press Release) – The U.S. Food and Drug Administration (FDA) has approved Sarclisa® (isatuximab-irfc) in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adults with relapsed refractory multiple myeloma (RRMM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. Sarclisa is expected to be available to patients in the U.S. shortly.
Sarclisa is a monoclonal antibody that binds to the CD38 receptor on multiple myeloma cells.
"Today's FDA approval …
Press Releases»

Silver Spring, MD (Press Release) – Today, the U.S. Food and Drug Administration approved Sarclisa (isatuximab-irfc), in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. Sarclisa, administered through intravenous (IV) infusion, is a CD38-directed cytolytic antibody that works by helping certain cells in the immune system attack multiple myeloma cancer cells.
“Targeting cells has led to the development of important oncology treatments. While there is no cure for multiple myeloma, Sarclisa is …
Press Releases»

Paris, France (Press Release) – The U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for isatuximab for the treatment of patients with relapsed / refractory multiple myeloma (RRMM). The target action date for the FDA decision is April 30, 2020. Isatuximab is an investigational monoclonal antibody that targets a specific epitope on the CD38 receptor of a plasma cell.
The BLA is based on positive results from ICARIA-MM, an open-label pivotal Phase 3 clinical trial of isatuximab in patients with RRMM. ICARIA-MM is the first positive randomized …