What do oncologists think of the IMROZ trial (SARCLISA®)?
IMROZ — 1L newly diagnosed multiple myeloma, transplant-ineligible (isatuximab + bortezomib, lenalidomide and dexamethasone)
FDA APPROVED · Sep 2024FDA-approved September 20, 2024, in combination with bortezomib, lenalidomide and dexamethasone for adults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant.
Physician voices — verbatim
Full physician voice list (25)
Full conference coverage and trial data: KOL Pulse trial profile coming soon.
What do oncologists think of the GMMG-HD7 trial (SARCLISA®)?
GMMG-HD7 — Transplant-eligible newly diagnosed multiple myeloma — isatuximab added to RVd induction (German GMMG academic trial)
INVESTIGATIONALInvestigational in this setting. GMMG-HD7 studied isatuximab added to RVd induction in transplant-eligible newly diagnosed multiple myeloma; isatuximab is not FDA-approved for transplant-eligible NDMM induction.
Physician voices — verbatim
Full physician voice list (16)
What do oncologists think of the IRAKLIA trial (SARCLISA®)?
IRAKLIA — Relapsed/refractory multiple myeloma — subcutaneous isatuximab (SARCLISA ESCENA via the CirCLIQ on-body injector) with pomalidomide and dexamethasone vs intravenous isatuximab, both with pomalidomide-dexamethasone
FDA APPROVED · subcutaneous · Jul 2026The subcutaneous isatuximab formulation (SARCLISA ESCENA, delivered via the CirCLIQ on-body injector) is FDA-approved (July 2026) across all existing intravenous Sarclisa multiple-myeloma indications, based on IRAKLIA — the first anticancer treatment administered via an on-body injector.
Physician voices — verbatim
Full physician voice list (10)
SARCLISA® — FDA status
FDA APPROVEDSARCLISA® (isatuximab) is FDA-approved for multiple myeloma — in newly diagnosed disease not eligible for transplant (with bortezomib, lenalidomide and dexamethasone) and in the relapsed/refractory setting (with carfilzomib–dexamethasone or pomalidomide–dexamethasone). A subcutaneous on-body-delivery formulation is also FDA-approved. Marketed by Sanofi. For the full, current list of FDA indications and prescribing information, see sarclisa.com or FDA label (DailyMed). KOL Pulse indexes the physician conversation; the label is owned and maintained by the manufacturer.
SARCLISA® sentiment — FAQ
IMROZ
What do oncologists think of the IMROZ trial (SARCLISA®)?
Across 25 verified physician voices in KOL Pulse's index for IMROZ, 32% expressed positive sentiment, 28% were nuanced (praising the result while flagging a caveat), 40% were neutral, and 0% were critical. Positive voices highlight the progression-free-survival benefit and deep MRD-negativity from adding isatuximab to VRd in transplant-ineligible newly diagnosed myeloma, bringing the anti-CD38 quadruplet to this population; nuanced and critical voices flag applicability to older or frailer patients, added infection/toxicity of a four-drug regimen, overall-survival maturity, and how it sequences against daratumumab-based quadruplets.
Where can I find the IMROZ trial data for SARCLISA® (isatuximab)?
IMROZ is registered as NCT03319667 and studied SARCLISA® (isatuximab) in 1L newly diagnosed multiple myeloma, transplant-ineligible (isatuximab + bortezomib, lenalidomide and dexamethasone). KOL Pulse's IMROZ trial profile is coming soon.
GMMG-HD7
What do oncologists think of the GMMG-HD7 trial (SARCLISA®)?
Across 16 verified physician voices in KOL Pulse's index for GMMG-HD7, 19% expressed positive sentiment, 6% were nuanced (praising the result while flagging a caveat), 75% were neutral, and 0% were critical. Positive voices highlight the improved MRD-negativity after induction from adding isatuximab to RVd in transplant-eligible newly diagnosed myeloma; nuanced and critical voices flag whether the post-induction MRD advantage will translate into a progression-free / overall-survival benefit, that the regimen is investigational (not FDA-approved), and the maintenance-strategy question.
Where can I find the GMMG-HD7 trial data for SARCLISA® (isatuximab)?
GMMG-HD7 is registered as NCT03617731 and studied SARCLISA® (isatuximab) in Transplant-eligible newly diagnosed multiple myeloma — isatuximab added to RVd induction (German GMMG academic trial). For the full GMMG-HD7 trial data and conference coverage, see the KOL Pulse GMMG-HD7 trial profile at kolpulse.com/kol-pulse-trial-profile-gmmg-hd7.
IRAKLIA
What do oncologists think of the IRAKLIA trial (SARCLISA®)?
Across 10 verified physician voices in KOL Pulse's index for IRAKLIA, 20% expressed positive sentiment, 20% were nuanced (praising the result while flagging a caveat), 60% were neutral, and 0% were critical. Positive voices highlight delivering isatuximab subcutaneously via an on-body injector with comparable efficacy and far shorter administration time than the intravenous infusion; nuanced and critical voices flag that this is a delivery-format advance rather than a new efficacy signal, and the logistics and real-world adoption of the on-body injector.
Where can I find the IRAKLIA trial data for SARCLISA® (isatuximab)?
IRAKLIA is registered as NCT05405166 and studied SARCLISA® (isatuximab) in Relapsed/refractory multiple myeloma — subcutaneous isatuximab (SARCLISA ESCENA via the CirCLIQ on-body injector) with pomalidomide and dexamethasone vs intravenous isatuximab, both with pomalidomide-dexamethasone. For the full IRAKLIA trial data and conference coverage, see the KOL Pulse IRAKLIA trial profile at kolpulse.com/kol-pulse-trial-profile-iraklia.
Regulatory
Is SARCLISA® (isatuximab) FDA approved?
SARCLISA® is FDA-approved. KOL Pulse organizes this page by clinical trial and links out to the manufacturer's brand site and the FDA label for the full, current list of FDA indications and prescribing information — the label is owned and updated by the manufacturer, so we point to it rather than reproducing it.