IRAKLIA trial supports FDA approval of first anticancer therapy delivered via on-body injector
A new FDA approval is changing how certain cancer therapies can be delivered.
The U.S. Food and Drug Administration (FDA) recently approved an on-body injector for Sarclisa Escena® (isatuximab-irfc), making it the first anticancer therapy in the United States available through this type of wearable device. WIVR is proud to have served as a participating site for the IRAKLIA Phase 3 clinical trial that contributed to the evidence supporting this approval.
Multiple myeloma is a rare type of cancer that forms in the plasma cells of the bone marrow, the body’s blood-forming system. When these cells become cancerous, they can interfere with the production of healthy blood cells and affect the body’s ability to fight infection. This disease can lead to kidney failure, bone disease, and increased risk of infections. While multiple myeloma is generally considered incurable, advances in treatment have made it increasingly manageable for many patients, with some experiencing long periods of remission.
From IV Infusion to On-Body Injector
Image source: Enable Injections
First approved in 2020 by the FDA, Sarclisa (isatuximab-irfc) is a medication that works by helping the immune system identify and attack myeloma cells. It is used in combination with other therapies to treat certain patients with multiple myeloma.
Until now, the medication has traditionally been administered by IV infusion, requiring extended time in infusion clinics. The newly approved formulation is delivered subcutaneously using the CirCLIQ® on-body injector, a wearable device designed to reduce hands-on time for clinical staff and shorten treatment administration time for patients.
Sanofi launched the IRAKLIA clinical trial in 2022, which was designed to evaluate whether this subcutaneous, on-body injection version of Sarclisa could provide comparable safety and effectiveness to the established IV formulation.
The randomized, open-label study enrolled 531 participants with relapsed or refractory multiple myeloma who had received at least one prior line of therapy. Participants were randomly assigned to receive either subcutaneous Sarclisa administered through the CirCLIQ® on-body injector or IV Sarclisa, both in combination with pomalidomide and dexamethasone. Results from the study demonstrated that subcutaneous administration achieved comparable efficacy, pharmacokinetic, and safety outcomes to IV delivery.
The subcutaneous formulation also reduced treatment administration time and resulted in fewer systemic administration reactions.
WIVR served as a participating site for the IRAKLIA trial, enrolling Veteran participants at the George E. Wahlen VA Medical Center in Salt Lake City.
The site was led by Principal Investigator Dr. Tsewang Tashi and Clinical Research Coordinators Denise Pessetto and Elle Brooks. The work of the research team and the Veterans who participated in the IRAKLIA trial contributed to the multicenter study that supported this FDA approval.
The approval of the Sarclisa Escena® on-body injector provides patients with multiple myeloma and their care teams with another option for treatment administration. WIVR is proud to have contributed to the research that supported this advancement.
Read more about the IRAKLIA trial and WIVR’s research here.
Disclaimer: WIVR is an independent clinical trial site and served as a participating site in the IRAKLIA clinical trial, sponsored by Sanofi. WIVR is not affiliated with, owned by, or a subsidiary of Sanofi, and does not speak on Sanofi’s behalf. Sarclisa, Sarclisa Escena, and related trademarks are the property of Sanofi. CirCLIQ and enFuse are trademarks of Enable Injections. This post is for informational purposes only and is not medical advice.
RESEARCH KEYWORDS:
multiple myeloma, relapsed refractory multiple myeloma, Isatuximab-irfc, Sarclisa Escena, Subcutaneous drug delivery, On-body injector technology, cancer treatment, clinical trial
