Sanofi US News

Sarclisa accepted for FDA priority review for the treatment of transplant-ineligible newly diagnosed multiple myeloma
  • FDA Priority Review granted based on positive results from IMROZ phase 3 study
  • If approved, Sarclisa would be the first anti-CD38 therapy in combination with standard-of-care treatment for patients with newly diagnosed transplant-ineligible multiple myeloma  
  • Pivotal IMROZ phase 3 study results to be featured during oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting

Paris, May 27, 2024. The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for the investigational use of Sarclisa (isatuximab-irfc) in combination with bortezomib, lenalidomide and dexamethasone (VRd) for the treatment of patients with transplant-ineligible newly diagnosed multiple myeloma (NDMM). If approved, Sarclisa would be the first anti-CD38 therapy in combination with standard-of-care VRd in newly diagnosed patients not eligible for transplant, which would be the third indication for Sarclisa in multiple myeloma. The target action date for the FDA decision is September 27, 2024. A regulatory submission is also under review in the European Union (EU).

Dietmar Berger, M.D., Ph.D.
Chief Medical Officer, Global Head of Development at Sanofi
“Despite recent advancements in multiple myeloma treatment, there remains a significant unmet need for new frontline therapies, particularly for transplant-ineligible patients who can face poor outcomes from the disease. The filing acceptances, as well as the FDA’s Priority Review designation, reinforce our confidence in Sarclisa as a potential best-in-class treatment and represent a critical step toward advancing this combination in a difficult-to-treat cancer.”

The sBLA, as well as the submission in the EU, is based on positive results from the IMROZ phase 3 clinical study evaluating the investigational use of Sarclisa in combination with standard-of-care VRd. In December 2023, the study met its primary endpoint at a planned interim analysis for efficacy, demonstrating statistically significant improvement in progression-free survival (PFS) with Sarclisa in combination with VRd compared with VRd alone in transplant-ineligible patients with NDMM. The safety and tolerability of Sarclisa observed in this study was consistent with the established safety profile of Sarclisa and VRd.

The IMROZ study is the fourth phase 3 study investigating Sarclisa combinations in NDMM patients to show superiority versus standard-of-care VRd and KRd, reinforcing its best-in-class potential. Results from the IMROZ study will also be featured during an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and during the plenary scientific session at the 2024 European Hematology Association (EHA) Annual Congress.

Priority Review is granted to regulatory applications seeking approval for therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions.

The investigational use of Sarclisa in combination with VRd in patients with transplant-ineligible NDMM is currently under clinical development, and its safety and efficacy for this indication have not been fully evaluated by any regulatory authority.

About the study

The global, randomized, multi-center, open-label IMROZ phase 3 clinical study enrolled 446 patients with newly diagnosed, transplant-ineligible MM across 21 countries and 104 centers. During the study, Sarclisa was administered through an intravenous infusion at a dose of 10 mg/kg once weekly for five weeks during first 42-day cycle and once every two weeks in cycles 2 to 4 in combination with subcutaneous bortezomib, oral lenalidomide and intravenous or oral dexamethasone. Then Sarclisa was administered every 2 weeks from cycle 5 to 17 and every 4 weeks in cycles 18+ during 28-day cycles in combination with lenalidomide and dexamethasone at the standard dose, until disease progression, unacceptable safety profile or patient’s decision to stop the study treatment.

The primary endpoint was progression-free survival. Key secondary endpoints include complete response rate, minimal residual disease (MRD) negativity rate for patients with a complete response, very good partial response or better rate, and overall survival. Other secondary endpoints were overall response rate, time to progression, duration of response, time to first response, time to best response, progression-free survival on next line of therapy, progression-free survival by MRD status, sustained MRD negativity greater than or equal to 12 months rate, safety, pharmacokinetic profile, immunogenicity, disease-specific and generic health-related quality of life, disease and treatment-related symptoms, health state utility, and health status.1

About Sarclisa

Sarclisa is a monoclonal antibody that binds to a specific epitope on the CD38 receptor on multiple myeloma (MM) cells, inducing distinct antitumor activity. It is designed to work through multiple mechanisms of action including programmed tumor cell death (apoptosis) and immunomodulatory activities. CD38 is highly and uniformly expressed on the surface of MM cells, making it a potential target for antibody-based therapeutics such as Sarclisa.

Based on the phase 3 ICARIA-MM study, Sarclisa is approved in >50 countries, including the U.S. and EU, in combination with pomalidomide and dexamethasone for the treatment of certain patients with relapsed refractory MM (RRMM) who have received ≥2 prior therapies, including lenalidomide and a proteasome inhibitor and who progressed on last therapy. Based on the phase 3 IKEMA study, Sarclisa is also approved in 50 countries in combination with carfilzomib and dexamethasone, including in the U.S. for the treatment of patients with RRMM who have received 1–3 prior lines of therapy and in the European Union for patients with MM who have received at least 1 prior therapy. In the U.S., the generic name for Sarclisa is isatuximab-irfc, with irfc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Administration (FDA).

Sarclisa continues to be evaluated in multiple ongoing phase 3 clinical studies in combination with current standard treatments across the MM treatment continuum. It is also under investigation for the treatment of other hematologic malignancies, and its safety and efficacy have not been evaluated by any regulatory authority outside of its approved indication.

For more information on Sarclisa clinical studies, please visit

About multiple myeloma

Multiple myeloma (MM) is the second most common hematologic malignancy,2 with more than 180,000 new diagnoses of MM worldwide yearly.3 Despite available treatments, MM remains an incurable malignancy with an estimated 52% five-year survival rate for newly diagnosed patients.4 Since MM does not have a cure, most patients will relapse. Relapsed MM is the term for when the cancer returns after treatment or a period of remission. Refractory MM refers to when the cancer does not respond or no longer responds to therapy.


What is SARCLISA?  

SARCLISA is a prescription medicine used in combination with:  

  • The medicines pomalidomide and dexamethasone, to treat adults who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor to treat multiple myeloma. 
  • The medicines carfilzomib and dexamethasone, to treat adults with multiple myeloma who have already received 1 to 3 lines of treatment and they did not work or are no longer working. 

It is not known if SARCLISA is safe and effective in children. 

Important Safety Information  

Do not receive SARCLISA if you have a history of a severe allergic reaction to isatuximab-irfc or any of the ingredients in SARCLISA (see the list of ingredients in the full Prescribing Information). 

Before receiving SARCLISA, tell your healthcare provider about all of your medical conditions, including if you:  

  • Have heart problems, if your healthcare provider prescribes SARCLISA in combination with carfilzomib and dexamethasone for you. 
  • Have had shingles (herpes zoster). 
  • Are pregnant or plan to become pregnant. SARCLISA may harm your unborn baby. You should not receive SARCLISA during pregnancy. 
    • Females who are able to become pregnant should use an effective method of birth control during treatment and for 5 months after your last dose of SARCLISA. Talk to your healthcare provider about birth control methods that you can use during this time. 
    • Tell your healthcare provider right away if you think you are pregnant or become pregnant during treatment with SARCLISA. 
  • Are breastfeeding or plan to breastfeed. It is not known if SARCLISA passes into your breast milk. You should not breastfeed during treatment with SARCLISA. 

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. 

How will I receive SARCLISA?  

  • SARCLISA will be given to you by your healthcare provider by intravenous (IV) infusion into your vein. 
  • SARCLISA is given in treatment cycles of 28 days (4 weeks), together with either the medicines pomalidomide and dexamethasone, or carfilzomib and dexamethasone. 
    • In cycle 1, SARCLISA is usually given weekly. 
    • Starting in cycle 2, SARCLISA is usually given every 2 weeks. 
  • If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment. 
  • Your healthcare provider will give you medicines before each dose of SARCLISA to help reduce the risk of infusion reactions (make them less frequent and severe). 

What are the possible side effects of SARCLISA?  

SARCLISA may cause serious side effects, including:  

  • Infusion reactions. Infusion reactions are common with SARCLISA and can sometimes be severe or life threatening.
    • Your healthcare provider will prescribe medicines before each infusion of SARCLISA to help decrease your risk for infusion reactions or to help make any infusion reaction less severe. You will be monitored for infusion reactions during each dose of SARCLISA. 
    • Your healthcare provider may slow down or stop your infusion, or completely stop treatment with SARCLISA if you have an infusion reaction. 

Get medical help right away if you develop any of the following symptoms of infusion reaction during or after an infusion of SARCLISA:  

—  shortness of breath, wheezing, or trouble breathing  
—  swelling of the face, mouth, throat, or tongue  
—  throat tightness  
—  palpitations  
—  dizziness, lightheadedness, or fainting  
—  headache  
—  cough  
—  rash or itching  
—  nausea  
—  runny or stuffy nose  
—  chills  

  • Decreased white blood cell counts. Decreased white blood cell counts are common with SARCLISA and certain white blood cells can be severely decreased. You may have an increased risk of getting certain infections, such as upper and lower respiratory tract infections and urinary tract infections. 

Your healthcare provider will check your blood cell counts during treatment with SARCLISA. Your healthcare provider may prescribe an antibiotic or antiviral medicine to help prevent infection, or a medicine to help increase your white blood cell counts during treatment with SARCLISA. 

Tell your healthcare provider right away if you develop any fever or symptoms of infection during treatment with SARCLISA. 

  • Risk of new cancers. New cancers have happened in people during treatment with SARCLISA. Your healthcare provider will monitor you for new cancers during treatment with SARCLISA. 
  • Change in blood tests. SARCLISA can affect the results of blood tests to match your blood type. Your healthcare provider will do blood tests to match your blood type before you start treatment with SARCLISA. Tell all of your healthcare providers that you are being treated with SARCLISA before receiving blood transfusions. 

The most common side effects of SARCLISA in combination with pomalidomide and dexamethasone include:  

  • upper respiratory tract infection  
  • lung infection (pneumonia)  
  • diarrhea  
  • decreased red blood cell count (anemia)  
  • decreased platelet count (thrombocytopenia) 

The most common side effects of SARCLISA in combination with carfilzomib and dexamethasone include:  

  • upper respiratory tract infection  
  • tiredness and weakness  
  • high blood pressure  
  • diarrhea  
  • lung infection (pneumonia)  
  • trouble breathing  
  • trouble sleeping  
  • bronchitis  
  • cough  
  • back pain  
  • decreased red blood cell count (anemia)  
  • decreased platelet count (thrombocytopenia)             

Heart failure can happen during treatment with SARCLISA in combination with carfilzomib and dexamethasone. Tell your healthcare provider right away if you develop any of the following symptoms:  

  • trouble breathing  
  • cough  
  • swelling of your ankles, feet, or legs  

These are not all the possible side effects of SARCLISA. For more information, ask your healthcare provider or pharmacist. 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit, or call 1-800-FDA-1088. 

Please see full Prescribing Information, including Patient Information. 

About Sanofi  

We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.  

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY 

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1 Accessed March 2024.
2 Kazandjian D. Multiple myeloma epidemiology and survival: A unique malignancy. Semin Oncol. 2016;43(6):676-681. doi:10.1053/j/seminoncol.2016.11.004.
3 World Health Organization. Multiple Myeloma. 35-multiple-myeloma-fact-sheet.pdf ( Accessed March 2024. 
4 Fonseca, R., Usmani, S.Z., Mehra, M. et al. Frontline treatment patterns and attrition rates by subsequent lines of therapy in patients with newly diagnosed multiple myeloma. BMC Cancer. 2020: 20(1087).