[{"orgOrder":0,"company":"Sanofi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"CHMP backs Sanofi\u2019s myeloma drug Sarclisa","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"FRANCE","productType":"Large molecule","productStatus":"Approved","date":"March 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Sanofi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"European Commission Approves Sarclisa\u00ae (isatuximab) for Adults with Relapsed And Refractory Multiple Myeloma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"FRANCE","productType":"Large molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Sanofi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"SARCLISA\u2122 (isatuximab for injection) Now Available in Canada for Patients with Relapsed and Refractory Multiple Myeloma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"FRANCE","productType":"Large molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Genmab","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Genmab Announces European Myeloma Network and Janssen Achieve Positive Topline Results from Phase 3 APOLLO Study of Daratumumab","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"DENMARK","productType":"Large molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Sanofi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sanofi's Sarclisa Bags NICE Recommendation","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"FRANCE","productType":"Large molecule","productStatus":"Approved","date":"October 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Karyopharm Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Karyopharm Announces XPOVIO\u00ae (Selinexor) Clinical Data to be Presented at the American Society of Hematology 2020 Annual Meeting","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"November 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Breckenridge Pharmaceutical","sponsor":"Natco Pharma","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Breckenridge Announces Final Approval of its ANDA for Pomalidomide Capsules (Generic for Pomalyst\u00ae)","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"November 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Johnson & Johnson Innovative Medicine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Janssen's APOLLO Study Show Clinically Meaningful Response with DARZALEX FASPRO\u00ae Regimen After First Relapse in Multiple Myeloma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"December 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Johnson & Johnson Innovative Medicine","sponsor":"European Myeloma Network","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Janssen Research & Development Reports Subcutaneous Daratumumab Extends Progression-Free Survival in Relapsed, Refractory Multiple Myeloma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"December 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Sanofi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Approves Sanofi's Sarclisa in Combination with Carfilzomib and Dexamethasone for Relapsed or Refractory Multiple Myeloma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"FRANCE","productType":"Large molecule","productStatus":"Approved","date":"March 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Sanofi","sponsor":"Blackstone Life Sciences","pharmaFlowCategory":"D","amount":"$330.0 million","upfrontCash":"Undisclosed","newsHeadline":"Sanofi Announces \u20ac300 Million Collaboration with Blackstone Life Sciences to Advance an Innovative Treatment for Multiple Myeloma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"FRANCE","productType":"Large molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Sanofi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New SARCLISA\u00ae (Isatuximab for Injection) Combination Now Approved by Health Canada for Adults with Relapsed and\/or Refractory Multiple Myeloma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"FRANCE","productType":"Large molecule","productStatus":"Approved","date":"October 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"CellCentric","sponsor":"Pfizer Inc","pharmaFlowCategory":"D","amount":"$25.0 million","upfrontCash":"Undisclosed","newsHeadline":"CellCentric Announces $25m Strategic Investment from Pfizer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Sanofi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sarclisa\u00ae (Isatuximab) Combination Provides Unprecedented Median Progression Free Survival in Patients With Relapsed Multiple Myeloma Receiving a Proteasome Inhibitor Therapy","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"FRANCE","productType":"Large molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Karyopharm Therapeutics","sponsor":"European Myeloma Network","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"The European Myeloma Network and Karyopharm Announce Dosing of First Patient in Collaborative EMN29\/XPORT-MM-031 Study","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Sanofi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"European Commission Approves Second Indication of Sarclisa\u00ae (isatuximab) for Relapsed Multiple Myeloma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"FRANCE","productType":"Large molecule","productStatus":"Approved","date":"April 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"CellCentric","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"CellCentric To Present Inobrodib Phase I Multiple Myeloma Efficacy And Safety Data At The American Society Of Haematology","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Johnson & Johnson Innovative Medicine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Janssen Presents First Data from MajesTEC-2 Trial of TECVAYLI\u00ae\u25bc (teclistamab) in Combination with DARZALEX\u00ae (daratumumab) Subcutaneous (SC) Formulation and Lenalidomide in Relapsed or Refractory Multiple Myeloma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"December 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Sanofi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Press Release: Sarclisa\u00ae (isatuximab) Plus KRd Significantly Improved Rate of Minimal Residual Disease Negativity in Transplant-Eligible Patients with Newly Diagnosed Multiple Myeloma versus KRd Alone","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Large molecule","productStatus":"Approved","date":"December 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"}]
Find Clinical Drug Pipeline Developments & Deals for Pomalidomide
Sarclisa (isatuximab) is a antibody that binds to a specific epitope on the CD38 receptor on multiple myeloma (MM) cells. It is being evaluated in phase 3 clinical trials in combination with carfilzomib, lenalidomide & dexamethasone (KRd) for the treatment ofMultiple Myeloma.
Latest results from Phase 3 IKEMA clinical trial for Sarclisa®(isatuximab-irfc) in combination with carfilzomib and dexamethasone demonstrated a median PFS of 35.7 months, compared to 19.2 months in patients treated with Kd alone.
For the Sarclisa® subcutaneous formulation delivery, Sanofi has partnered with drug delivery technology innovator company to advance the development of a subcutaneous delivery for Sarclisa® with the goal of offering a unique patient-centric treatment experience.
SARCLISA® continues to be evaluated in multiple ongoing Phase 3 clinical trials in combination with current standard treatments across the MM treatment continuum. It is also under investigation for the treatment of other hematologic malignancies and solid tumours.
Sarclisa is a monoclonal antibody that binds to a specific epitope on the CD38 receptor on MM cells. It is designed to work through multiple mechanisms of action including programmed tumor cell death (apoptosis) and immunomodulatory activity.
The decision follows the Phase III IKEMA trial, which featured 302 patients with relapsed multiple myeloma across 69 centers spanning 16 countries. The study found that Sarclisa added to Kd reduced the risk of disease progression or death by 45%, versus Kd alone.
Sarclisa (isatuximab) has been recommended in combination with pomalidomide and dexamethasone in relapsed/refractory multiple myeloma who have received three prior lines of treatment, including lenalidomide and proteasome inhibitor.
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 trial.
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).
Market Place
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme. 
Contact Supplier
