Sanofi has scored FDA approval for its subcutaneous version of Sarclisa, giving the multiple myeloma treatment a potential boost in its competition with Johnson & Johnson’s powerhouse Darzalex.
Sanofi’s new formulation, which is dubbed Sarclisa Escena, now becomes the first subcutaneous anticancer drug that can be administered manually or by an on-body injector (OBI). The endorsement for Sarclisa Escena applies to each of the indications for which its intravenous (IV) formulation is approved.
The endorsement was backed by multiple trials, including the phase 3 Iraklia study, which was the first to use an OBI in dosing multiple myeloma patients and showed that Sarclisa Escena reduced treatment time and produced similar efficacy and safety compared to the drug's IV formulation.
Sarclisa Escena administered via an OBI in combination with Bristol Myer’s Squibb’s Pomalyst and the corticosteroid dexamethasone (Pd) yielded a 71.1% objective response rate (ORR), compared to 70.5% with Sarclisa IV-Pd, establishing non-inferiority in adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of treatment.
Sarclisa Escena is delivered by Enable Injections’ CirCLIQ’ hands-free automated device. The Cincinnati-based company gained its first FDA approval three years ago for its enFuse OBI to administer Apellis Pharmaceuticals’ paroxysmal nocturnal hemoglobinuria drug Empaveli. The device employs a retractable 30g needle that is shorter and thinner compared to the needles commonly used for large-volume injections, Sanofi said.
Introduction of the OBI option “represents a significant advancement in multiple myeloma care,” Donna Catamero, the Associate Director, Myeloma Research at Mount Sinai Phillips School of Nursing, said in a release.
“For nurses and physicians treating patients with multiple myeloma, this automated system has the potential to meaningfully reduce administrative burden, simplifying how therapy is delivered and giving healthcare teams more capacity to focus on their patients,” Catamero added.
The innovation also gives Sanofi a better chance to vie with J&J. While Sarclisa and Darzalex are from the same CD38 drug class, Darzalex reached the market five years earlier (2015), and gained a nod for its subcutaneous version, Darzalex Faspro, in 2020.
Darzalex rung up sales of $14.4 billion in 2025, which were up 23%, while Sanofi reported sales of Sarclisa at 588 euros ($700 million), good for an increase of 28%.
“Sarclisa is the cornerstone of our oncology franchise and we have always been confident in it being widely adopted as a potential best-in-class therapy,” Manuela Buxo, EVP and Sanofi’s Head of Specialty Care, said in a statement.
Sarclisa is approved in three indications, including first-line use in patients who are not eligible for stem cell transplant. In this indication, Sarclisa is added to J&J and Takeda’s Velcade, plus Bristol Myers Squibb’s Revlimid and the corticosteroid dextamethasone.
Sarclisa was originally approved in combination with Pd for patients who had received at least two prior therapies, including Revlimid and a protease inhibitor such as Velcade. It also was endorsed for second-line use with Amgen’s Kyprolis and dextamethasone.
The FDA was originally scheduled to decide on the new version of Sarclisa by April 22 before pushing back the date by three months. In June, Europe signed off on subcutaneous Sarclisa, making it the first anticancer therapy that could be delivered by an OBI in the bloc.