Sanofi's Sarclisa Subcutaneous Formulation Recommended for EU Approval

Sarclisa SC would be the first anticancer treatment administered via on-body injector in the EU

Mar. 27, 2026 at 2:27pm

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The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Sanofi's Sarclisa (isatuximab) subcutaneous (SC) formulation in combination with approved standard-of-care regimens for the treatment of patients with multiple myeloma (MM) across all currently approved indications for Sarclisa intravenous (IV) formulation in the EU. If approved, Sarclisa SC would be the first available anticancer treatment to be administered through an on-body injector (OBI) and the first multiple myeloma medicine available by both SC OBI and manual injection in the EU.

Why it matters

The recommendation for Sarclisa SC is a significant milestone in improving the treatment experience for multiple myeloma patients and providers. Subcutaneous delivery via an on-body injector can provide greater convenience and flexibility compared to intravenous infusion, which may lead to better patient outcomes and healthcare system efficiencies.

The details

The positive CHMP opinion is based on results from several clinical studies, including the IRAKLIA phase 3 study in relapsed and/or refractory (R/R) MM, which demonstrated non‑inferiority of the SC formulation compared to the IV formulation. Additional studies, such as the GMMG-HD8 phase 3 study in transplant-eligible newly diagnosed MM, the IZALCO phase 2 study in R/R MM, and the ISASOCUT phase 2 study in transplant-ineligible newly diagnosed MM, also supported the decision. Two studies showed that the use of Sarclisa SC + OBI was associated with greater patient satisfaction and preference compared to IV administration and manual injection.

  • The CHMP adopted a positive opinion recommending the approval of Sarclisa SC on March 27, 2026.
  • A final decision from the European Medicines Agency is expected in the coming months.

The players

Sanofi

A global biopharmaceutical company committed to improving people's lives and delivering compelling growth through innovative, first and best-in-class immunological and targeted therapies for rare and difficult-to-treat cancers.

European Medicines Agency (EMA)

The regulatory body responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the European Union.

Committee for Medicinal Products for Human Use (CHMP)

The EMA committee responsible for preparing the Agency's opinions on all questions concerning medicines for human use.

Enable Injections

A global healthcare innovation company that developed the enFuse® On-Body Delivery System, an innovative wearable technology designed to deliver large volumes of pharmaceutical and biologic therapeutics via subcutaneous administration.

Olivier Nataf

Global Head of Oncology at Sanofi.

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What they’re saying

“This positive CHMP opinion is a pivotal milestone in our mission to improve the treatment experience for multiple myeloma patients and providers. Our aim is to evolve the treatment experience by combining the clinically proven efficacy of Sarclisa with innovative subcutaneous delivery via an on-body injector. This advancement reflects our unwavering commitment to patients and dedication to transforming care in ways that truly matter to people living with cancer.”

— Olivier Nataf, Global Head of Oncology at Sanofi

What’s next

A final decision from the European Medicines Agency on the approval of Sarclisa subcutaneous formulation is expected in the coming months.

The takeaway

The recommendation for Sarclisa subcutaneous formulation administered via an on-body injector represents a significant advancement in multiple myeloma treatment, as it has the potential to improve the patient experience and healthcare system efficiencies compared to traditional intravenous administration.