The FDA has approved a subcutaneous formulation of isatuximab (Sarclisa Escena, Sanofi) for multiple myeloma, making it the first anticancer therapy deliverable via a hands-free on-body injector (OBI). The approval covers three indications — including newly diagnosed and relapsed/refractory MM — matching those of the existing IV formulation. Clinical trials showed response rates comparable to or exceeding the IV version.
The FDA has approved Sarclisa Escena, a subcutaneous version of isatuximab (Sanofi), for multiple myeloma (MM) — and it comes with a notable delivery upgrade. The drug can now be administered via the CirCLIQ on-body injector (OBI), a hands-free automated device, making it the first anticancer treatment approved for OBI delivery and the first MM therapy available through both OBI and manual subcutaneous administration in the US.
The approval covers three indications: in combination with pomalidomide/dexamethasone for patients with at least one prior line of therapy; with carfilzomib/dexamethasone for relapsed/refractory MM after one to three prior lines; and with bortezomib/lenalidomide/dexamethasone for newly diagnosed patients ineligible for stem cell transplant.
By the Numbers:
Why it matters: Subcutaneous delivery with a hands-free injector could meaningfully reduce infusion chair time and clinic burden, offering a more convenient option for both patients and healthcare providers managing MM.
