Sanofi: FDA Approves Sarclisa Escena, First Cancer Drug via Portable Injector
The FDA has approved the subcutaneous formulation of Sarclisa, administered via an on-body injector, for the treatment of multiple myeloma. The drug becomes the first cancer treatment deliverable through this type of automated device.
A Subcutaneous Formulation Paired with a Portable Injector
Sanofi has received FDA approval for Sarclisa Escena in combination with standard-of-care regimens for the treatment of multiple myeloma (MM). This formulation is administered via the Enable Injections' CirCLIQ on-body injector, based on the enFuse platform. Sarclisa Escena becomes the first cancer treatment available via a portable injector and the first MM treatment in the U.S. offering both on-body injector and manual injection administration. The device uses a retractable 30 gauge needle, which is shorter and thinner than those typically used for large-volume injections.
Efficacy Confirmed by IRAKLIA Trial
The approval is based on multiple studies, including the phase 3 IRAKLIA trial, which demonstrated the non-inferiority of subcutaneously administered Sarclisa Escena via the portable injector compared to intravenous infusion. In this trial, Sarclisa SC in combination with pomalidomide and dexamethasone achieved an objective response rate (ORR) of 71.1% (187/263 patients), compared to 70.5% (189/268 patients) with Sarclisa IV. The study recorded a safety profile consistent with that of Sarclisa IV, with 25% of patients treated with Sarclisa IV experiencing systemic administration reactions, versus 1.5% of patients treated with Sarclisa SC. Injection site reactions were observed in 0.4% of injections via the portable injector (19 cases out of 5145 injections), nearly all of grade 1 except for one grade 2 case.
Usage Framework and Regulatory Developments
Sarclisa is currently approved in the U.S. for three indications: in combination with bortezomib, lenalidomide, and dexamethasone for patients with newly diagnosed multiple myeloma not eligible for autograft; in combination with pomalidomide and dexamethasone for patients with relapsed or refractory disease who have received at least two prior therapies; and in combination with carfilzomib and dexamethasone for patients who have received one to three prior lines of treatment. Sanofi reports that over 70,000 patients worldwide have benefited from Sarclisa. In Japan, the subcutaneous formulation for manual injection is approved, and a regulatory application concerning the CirCLIQ on-body injector is currently under review.
