Sanofi wins Japan approval for Sarclisa subcutaneous formulation
Japan's Ministry of Health, Labour and Welfare has approved Sanofi's subcutaneous formulation of Sarclisa (isatuximab) for the treatment of multiple myeloma, covering both the relapsed or refractory and newly diagnosed settings. The decision, announced on 19 June 2026, makes Japan the second market to grant approval for Sarclisa SC after the European Union, which cleared the formulation earlier the same month.
The approved indications in Japan span combination use with pomalidomide and dexamethasone (Pd) or with carfilzomib for relapsed or refractory multiple myeloma, as well as combination with bortezomib, lenalidomide, and dexamethasone (VRd) for newly diagnosed adult patients. Sarclisa IV already holds five approved indications in Japan, and the new SC approval runs in parallel across the core regimens.
IRAKLIA trial data
The approval rests principally on results from the IRAKLIA phase 3 study (NCT05405166), a randomised, open-label trial assessing non-inferiority of a fixed-dose SC formulation against weight-based intravenous dosing, both in combination with Pd, in relapsed or refractory patients who had received at least one prior line of therapy.
The SC arm delivered an objective response rate of 71.1%, compared with 70.5% in the IV arm, meeting the pre-specified non-inferiority criterion with a risk ratio of 1.008 (95% CI: 0.903 to 1.126; p=0.0006). On the safety side, infusion reactions fell markedly: 25% of patients in the IV arm experienced such reactions versus 1.5% in the SC arm. Local injection site reactions were observed in 0.4% of on-body injector administrations, with nearly all graded as grade 1. Grade 3 or higher haematologic abnormalities were consistent with the established isatuximab profile, with neutropenia the most common event in both arms.
Olivier Nataf, Global Head of Oncology at Sanofi, said the new formulation "significantly eases treatment burden and enhances convenience for patients compared to intravenous administration."
On-body injector and competitive context
A separate regulatory submission covering the CirCLIQ on-body injector (OBI), built on Enable Injections' enFuse platform, is currently under review by Japanese authorities. If approved, Sarclisa SC would become the first anticancer therapy administered via an OBI in Japan. In the EU and UK, Sarclisa SC has already secured that distinction. A US application for the SC formulation remains under review.
The on-body injector angle is commercially meaningful. In the multiple myeloma space, where anti-CD38 antibodies have become a standard backbone across lines of therapy, differentiation increasingly comes from convenience and tolerability rather than mechanism. Sanofi's main anti-CD38 competitor, Johnson and Johnson's daratumumab (Darzalex), has had a subcutaneous formulation available since 2020, and the SC format has driven substantial share gains for that product by reducing chair time and improving patient experience. The belated arrival of Sarclisa SC narrows that gap, and the OBI option, if approved, could offer a further point of differentiation by enabling hands-free self-administration.
Multiple myeloma is the third most common haematologic malignancy in Japan, and new diagnoses have been rising steadily, according to Sanofi's own figures in the release. Isatuximab-based regimens have now been used to treat more than 70,000 patients globally across nearly 60 countries. The expanding front-line indication, via the VRd triplet combination, is particularly significant commercially, given that newly diagnosed patients represent a larger and more durable treatment population than the relapsed setting.
A US approval decision for the SC formulation would be the next material catalyst for the programme, and Sanofi has not given a timeline for that outcome beyond confirming the application is under review.