The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the approval of isatuximab (SARCLISA) subcutaneous formulation to treat patients with multiple myeloma. The recommendation covered all currently approved indications for the intravenous formulation in the European Union, including both newly diagnosed and relapsed or refractory disease.
If approved by the European Commission, isatuximab would be the first anticancer treatment administered through an on-body injector or manual injection. A regulatory submission for the subcutaneous formulation was also under review with the US Food and Drug Administration.
The recommendation was based on results from the phase 3 IRAKLIA trial, which demonstrated that the subcutaneous formulation was noninferior to intravenous administration in patients with relapsed or refractory MM.
Additional data from the phase 3 GMMG-HD8 study and the IZALCO and ISASOCUT phase 2 trials supported the comparable efficacy and safety profile of the treatment, according to the press release by Sanofi.
“This positive CHMP opinion is a pivotal milestone in our mission to improve the treatment experience for multiple myeloma patients and providers,” said Olivier Nataf, global head of oncology at Sanofi, in the press release.
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