Sanofi’s Sarclisa Escena Receives FDA Approval as First Oncology Drug Delivered Through On-Body Injector

The FDA has approved Sarclisa Escena, a subcutaneous on-body injector formulation of Sanofi’s multiple myeloma therapy isatuximab, becoming the first cancer treatment authorised in the US for delivery through an on-body injector system.

Sanofi has secured US Food and Drug Administration (FDA) approval for Sarclisa Escena, a new subcutaneous (SC) formulation of its multiple myeloma therapy Sarclisa (isatuximab-irfc) delivered through an on-body injector (OBI).

The approval represents a milestone in oncology drug delivery, as Sarclisa Escena becomes the first cancer therapy approved in the US that can be administered using an on-body injector alongside manual subcutaneous injection.

Sarclisa Escena is approved across all existing US indications for the intravenous (IV) formulation of Sarclisa in multiple myeloma, providing healthcare professionals and patients with an additional treatment administration option.

New Sarclisa Formulation Expands Multiple Myeloma Treatment Options

Multiple myeloma is a blood cancer caused by the abnormal growth of plasma cells in the bone marrow, leading to complications including bone damage, anaemia, kidney problems and weakened immune function.

Sarclisa is a monoclonal antibody targeting CD38, a protein expressed on multiple myeloma cells. By binding to CD38, the therapy helps activate immune mechanisms that attack and eliminate cancer cells.

The newly approved Sarclisa Escena formulation allows the medicine to be delivered subcutaneously through either:

• The CirCLIQ on-body injector (OBI), providing automated hands-free administration.

• Manual subcutaneous injection, offering additional flexibility for healthcare providers.
  

The approval covers Sarclisa’s existing US indications, including use in combination treatment regimens for patients with relapsed or refractory multiple myeloma and newly diagnosed disease.

Phase III IRAKLIA Trial Supports FDA Approval

The FDA approval was supported by clinical data from multiple studies, including the Phase III IRAKLIA non-inferiority trial.

The study compared Sarclisa Escena delivered through the CirCLIQ on-body injector with the existing intravenous formulation in patients with multiple myeloma.

In IRAKLIA, patients receiving Sarclisa Escena alongside pomalidomide and dexamethasone achieved an objective response rate (ORR) of 71.1%.

This compared with an ORR of 70.5% among patients receiving the intravenous Sarclisa formulation with the same treatment combination.

The trial demonstrated that the subcutaneous on-body injector formulation achieved comparable:

• Efficacy outcomes

• Pharmacokinetic exposure

• Overall safety profile
  

compared with the established IV formulation.

On-Body Injector Technology Reduces Treatment Burden

The CirCLIQ on-body injector was developed using Enable Injections’ enFuse platform, a technology designed to simplify the administration of large-volume injectable medicines.

The wearable device uses a retractable 30-gauge needle and is designed to automatically deliver the medicine without requiring healthcare professionals to manually administer prolonged injections.

Sanofi said the system aims to reduce the physical effort associated with delivering high-resistance injections while allowing healthcare professionals to spend more time monitoring patients during treatment.

The technology could help improve the treatment experience for patients receiving long-term cancer therapies by reducing administration complexity and shortening time spent in clinical settings.

Sarclisa Escena Demonstrates Comparable Safety Profile

Safety findings from the IRAKLIA trial were consistent with the known safety profile of intravenous Sarclisa.

However, the subcutaneous on-body injector formulation demonstrated a reduction in systemic administration-related reactions.

Systemic administration reactions occurred in:

• 1.5% of patients receiving Sarclisa Escena

• 25% of patients receiving intravenous Sarclisa
  

The results suggest that the new delivery method may provide a more convenient administration approach without compromising the established clinical profile of the therapy.

Impact on the Future of Oncology Drug Delivery

The FDA approval of Sarclisa Escena reflects a wider shift towards improving convenience and reducing treatment burden in oncology.

As more cancer therapies move beyond traditional intravenous infusion models, pharmaceutical companies are increasingly exploring alternative delivery technologies that can support outpatient treatment, improve patient experience and optimise healthcare resources.

Sanofi’s approval of Sarclisa Escena positions the company at the forefront of this movement, introducing the first FDA-approved oncology treatment delivered through an on-body injector.

Why This Approval Matters

The approval of Sarclisa Escena provides patients with multiple myeloma and healthcare providers with a new way to administer an established therapy.

By combining comparable efficacy and safety with a potentially simpler delivery method, the treatment could help reduce the burden associated with long-term cancer care.

The decision also highlights the growing importance of drug delivery innovation alongside advances in oncology therapeutics, as companies seek to make complex treatments more accessible and patient-friendly.

Summary

Sanofi has received FDA approval for Sarclisa Escena, a subcutaneous on-body injector formulation of its multiple myeloma therapy isatuximab.

Supported by Phase III IRAKLIA data, the therapy demonstrated comparable efficacy and safety to intravenous Sarclisa while significantly reducing administration-related reactions and treatment complexity.

The approval marks the first FDA-approved oncology drug delivered through an on-body injector and represents a significant advance in the evolution of cancer treatment delivery.

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