Paris, April 22, 2026. The US Food and Drug Administration (FDA) has extended by up to three months the target action date for its review of the biologics license application for Sarclisa (isatuximab-ifrc) subcutaneous (SC) in combination with approved standard-of-care regimens for the treatment of patients with multiple myeloma (MM) across all currently approved US indications of Sarclisa intravenous (IV) formulation. The revised target action date for the FDA decision is July 23, 2026.
Sanofi is committed to working closely with the FDA to bring this new advancement to patients and providers as quickly as possible. If approved, Sarclisa would be the first anticancer treatment to be administered through an on-body injector (OBI).
On March 26, 2026, the European Medicine Agency Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of Sarclisa SC administered via both an OBI and manual injection for the treatment of MM patients across all currently approved indications and combinations for Sarclisa IV formulation in the EU. A final decision is expected in the coming months.
About Sarclisa
Sarclisa (isatuximab-irfc) has been approved in almost 60 countries across four indications for certain patients with newly diagnosed MM and relapsed or refractory MM. Sarclisa-based regimens have been prescribed to treat more than 60,000 patients worldwide.
At Sanofi, we are building on a long-standing commitment to oncology as we continue to chase the miracles of science to improve the lives of those living with cancer. We are committed to transforming cancer care by developing innovative, first and best-in-class immunological and targeted therapies for rare and difficult-to-treat cancers with high unmet need.
For more information on Sarclisa clinical studies, please visit www.clinicaltrials.gov.
IMPORTANT SAFETY INFORMATION AND INDICATION FOR US PATIENTS
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.
- The medicines bortezomib, lenalidomide and dexamethasone, to treat adults with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant).
It is not known if SARCLISA is safe and effective in children.
Important Safety Information
Do not receive SARCLISA if you have 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 an infection.
- 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 can harm your unborn baby.
- 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.
- Before receiving SARCLISA in combination with either pomalidomide or lenalidomide, females and males must agree to the instructions in the pomalidomide or lenalidomide REMS program. The pomalidomide and lenalidomide REMS program have specific requirements about birth control, pregnancy testing, blood donation, and sperm donation that you need to know. Talk to your healthcare provider to learn more about pomalidomide or lenalidomide.
- Are breastfeeding or plan to breastfeed. It is not known if SARCLISA passes into your breast milk. Do 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 in combination with pomalidomide and dexamethasone, or SARCLISA in combination with carfilzomib and dexamethasone is given in treatment cycles of 28 days (4 weeks).
- Cycle 1 (28-day cycle), SARCLISA is given weekly.
- Cycle 2 and beyond (28-day cycles), SARCLISA is given every 2 weeks.
- SARCLISA in combination with bortezomib, lenalidomide, and dexamethasone is given in treatment cycles of 42 days (6 weeks) from cycle 1 to 4 and in treatment cycles of 28 days (4 weeks) from cycle 5.
- Cycle 1 (42-day cycle), SARCLISA is given weekly (Days 1, 8, 15, 22, and 29).
- Cycles 2 to 4 (42-day cycles), SARCLISA is given every 2 weeks (Days 1, 15, and 29).
- Cycles 5 to 17 (28-day cycles), SARCLISA is given every 2 weeks (Days 1 and 15).
- Cycles 18 and beyond (28-day cycles), SARCLISA is given every 4 weeks.
- Your healthcare provider will decide how many treatments you will receive.
- Your healthcare provider will give you medicines before each infusion of SARCLISA to help reduce the risk of infusion reactions (make them less frequent and severe).
- If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.
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 infusion 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:
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- Infections. SARCLISA can cause infections that are severe, life-threatening, or that may lead to death. Your healthcare provider will monitor you for signs and symptoms of infection before and during treatment with SARCLISA. Your healthcare provider may prescribe medicines for you to help prevent infections and treat you as needed if you develop an infection during treatment with SARCLISA. Tell your healthcare provider right away if you develop a fever or any signs or symptoms of infection during treatment with SARCLISA.
- Decreased white blood cell counts. Decreased white blood cell counts are common with SARCLISA and certain white blood cells can be severely decreased. Fever can occur with low white blood cell counts and may be a sign that you have an infection. Your healthcare provider will check your blood cell counts during treatment with SARCLISA and may prescribe a medicine to help increase your white blood cell counts. 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 and after treatment with SARCLISA. Your healthcare provider will monitor you for new cancers during treatment with SARCLISA.
- Change in blood tests. SARCLISA may affect the results of blood tests to match your blood type for about 6 months after your last infusion of SARCLISA. 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:
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The most common side effects of SARCLISA in combination with carfilzomib and dexamethasone include:
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The most common side effects of SARCLISA in combination with bortezomib, lenalidomide and dexamethasone include:
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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 www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see accompanying full Prescribing Information, including Patient Information.
About Sanofi
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
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