Sanofi’s subcutaneous formulation of Sarclisa has been approved in Japan for use with Pd or carfilzomib in relapsed/refractory multiple myeloma and with VRd for newly diagnosed patients. The IRAKLIA Phase III trial showed non‑inferior efficacy and comparable pharmacokinetics to the IV formulation, with ORRs of 71.1% (SC‑Pd via OBI) vs 70.5% (IV‑Pd). Sarclisa SC demonstrated substantially fewer infusion‑related reactions (1.5% vs 25%), and a submission for the CirCLIQ on‑body injector is under regulatory review.
Japan Approves Sanofi’s Subcutaneous Sarclisa for Multiple Myeloma — On‑Body Injector Option Under Review
Pivotal data from the IRAKLIA Phase III study showed a 71.1% ORR for Sarclisa SC-Pd via OBI. Credit: luchschenF / Shutterstock.com.(luchschenF / Shutterstock.com.)
Sanofi has won approval from Japan’s Ministry of Health, Labour and Welfare for a subcutaneous (SC) formulation of Sarclisa (isatuximab) to be used in combination with established therapies for multiple myeloma (MM).
The decision follows positive results from the pivotal IRAKLIA Phase III trial, which showed the SC formulation to be non‑inferior to the intravenous (IV) version in efficacy and pharmacokinetics. This is the second major regulatory approval for Sarclisa SC after authorisation in the European Union.
Approved Indications: The Japanese licence covers Sarclisa SC in combination with pomalidomide and dexamethasone (Pd) or with carfilzomib for adults with relapsed or refractory multiple myeloma (r/r MM). It is also approved with bortezomib, lenalidomide and dexamethasone (VRd) for newly diagnosed multiple myeloma (NDMM) in adults.
Pivotal IRAKLIA Data
IRAKLIA demonstrated a 71.1% objective response rate (ORR) for Sarclisa SC plus Pd when administered via the CirCLIQ on‑body injector (OBI), compared with a 70.5% ORR for IV‑Pd—meeting non‑inferiority criteria. Pharmacokinetic results were likewise comparable between SC and IV formulations.
Safety Profile
Sanofi reported that Sarclisa SC showed a safety profile consistent with the established IV formulation but with substantially fewer infusion‑related reactions (1.5% for SC‑Pd vs 25% for IV‑Pd). The most frequent grade ≥3 non‑haematologic adverse events were pneumonia, Covid‑19 and upper respiratory tract infection. Common grade ≥3 haematologic laboratory abnormalities included neutropenia, thrombocytopenia and anaemia.
Device Submission and Administration Options
A regulatory submission for the CirCLIQ on‑body injector (built on Enable Injections’ enFuse platform) remains under review in Japan. If cleared, CirCLIQ would enable on‑body administration of Sarclisa SC and could become Japan’s first anti‑cancer therapy delivered via an OBI. Sarclisa SC will also be available for manual subcutaneous injections, preserving flexibility in clinical practice.
Regulatory Context: In Japan, the IV formulation of Sarclisa is already approved for five indications, including multiple relapsed/refractory regimens and NDMM. The SC formulation has been authorised across the same indications in the EU and is under review by US regulators.
Corporate Note
Sanofi Oncology Global Head Olivier Nataf said the SC approval “represents an important evolution in how we deliver care for multiple myeloma patients in Japan,” highlighting improved convenience and reduced treatment burden compared with IV administration.
Separately, Sanofi recently entered a multi‑year collaboration with France‑based AI company Owkin to co‑develop next‑generation, AI‑driven biopharma agents, reflecting the company’s broader digital and R&D strategy.
Disclaimer: This article summarizes Sanofi’s announcement and trial data for informational purposes only and is not medical advice. Consult clinical guidelines or specialist advice for treatment decisions.
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