The European Commission has approved a subcutaneous version of isatuximab, marketed as Sarclisa, to be delivered with the CirCLIQ on‑body injector (OBI) for all approved multiple myeloma indications in the EU, expanding treatment beyond traditional intravenous infusion.
Clinical data underpinning the approval
The decision follows pooled safety data from 349 patients who together received 6,426 injections across three trials: the phase 3 IRAKLIA (NCT05405166), phase 2 IZALCO (NCT05704049) and phase 1B TCD15484. The cross‑trial analysis reported infusion‑related reactions in only 0.09 % of administrations, markedly lower than rates seen with IV or manual‑push subcutaneous formulations. Nearly all adverse events were graded mild, and none led to treatment discontinuation.
Device performance was similarly strong, with 99.9 % of injections completed without interruption. Injection‑site reactions were uncommon and largely mild, supporting the OBI’s safety profile for routine use.
Implications for patients and care teams
Dr. Xavier Leleu, lead investigator of the IRAKLIA trial, emphasized that the subcutaneous formulation aligns with the goal of making myeloma a chronic, manageable condition. “Isatuximab has proved safe and very active for patients, particularly in the quadruplet‑based regimen we have developed recently to propose a very prolonged survival,” he said.
He noted that the original IV format was essential for early development, but the shift to a subcutaneous delivery “is simpler, faster, safer, and more convenient.” The OBI, unlike a manual‑push device, automates the injection process, reducing the need for nursing oversight during each dose.
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The OBI eases clinic workload.
From a practical standpoint, the low reaction rate means the first dose can be administered in an outpatient setting without prolonged observation, opening the possibility of home‑based treatment. This could ease the workload on oncology clinics, where staffing shortages are a persistent challenge.
For patients, the convenience translates into fewer clinic visits and the ability to self‑administer after an initial supervised dose. In regions where nursing resources are stretched thin, the OBI may help preserve staff time by eliminating the need to reconstitute syringes and monitor infusions.
The approval may set a precedent for other monoclonal antibodies used in hematologic cancers, encouraging manufacturers to pursue similar on‑body delivery systems.
While the data are promising, real‑world implementation will test whether the theoretical time savings materialize in busy hospitals. Ongoing monitoring will be needed to confirm that the low infusion‑related reaction rate holds outside controlled trial environments.
