Articles tagged with: Sarclisa

Press Releases»

[ by | Jul 8, 2020 7:15 am | Comments Off ]
  • 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

Sarclisa (Isatuximab For Injection) Now Available In Canada For Patients With Relapsed And Refractory Multiple Myeloma 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. …

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Press Releases»

[ by | Jun 2, 2020 6:47 am | Comments Off ]
  • 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

European Commission Approves Sarclisa (Isatuximab) For Adults With Relapsed And Refractory Multiple Myeloma 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 …

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Press Releases»

[ by | May 12, 2020 1:00 am | Comments Off ]
  • 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

Sarclisa (Isatuximab) Phase 3 IKEMA Trial Meets Primary Endpoint Early In Patients With Relapsed Multiple Myeloma 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 …

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Press Releases»

[ by | Mar 27, 2020 2:05 am | Comments Off ]
  • 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

Sanofi Receives Positive CHMP Opinion For Sarclisa (Isatuximab) For The Treatment Of Relapsed And Refractory Multiple Myeloma 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 …

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Press Releases»

[ by | Mar 2, 2020 2:42 pm | Comments Off ]
  • 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

FDA Approves Sarclisa (Isatuximab-irfc) For Patients With Relapsed Refractory Multiple Myeloma 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 …

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Press Releases»

[ by | Mar 2, 2020 2:15 pm | Comments Off ]
FDA Approves New Therapy For Patients With Previously Treated Multiple Myeloma

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 …

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Press Releases»

[ by | Jul 10, 2019 1:00 am | Comments Off ]
FDA To Review Isatuximab As A Potential Treatment For Relapsed / Refractory Multiple Myeloma

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 …

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