Sanofi’s Sarclisa subcutaneous formulation recommended for approval to treat multiple myeloma

Sanofi announces that the EMA’s CHMP has adopted a positive opinion recommending the approval of Sarclisa subcutaneous in combination with approved standard-of-care regimens for the treatment of patients with multiple myeloma  across all currently approved indications for Sarclisa intravenous formulation in the EU. If this becomes approved, Sarclisa would be the first available anticancer treatment to be administered through both an on-body injector and manual injection, and the only anti-CD38 monoclonal antibody available in MM to offer the flexibility of both an OBI and manual injection.

“This positive CHMP opinion is a pivotal milestone in our mission to improve the treatment experience for multiple myeloma patients and providers,” says Olivier Nataf, Global Head of Oncology at Sanofi. “Our aim is to evolve the treatment experience by combining the clinically proven efficacy of Sarclisa with innovative subcutaneous delivery via an on-body injector. This advancement reflects our unwavering commitment to patients and dedication to transforming care in ways that truly matter to people living with cancer.”

Note that of the multiple SC studies two studies showed the use of Sarclisa SC + OBI was associated with greater patient satisfaction compared to IV administration, and patient and healthcare provider preference compared to Sarclisa manual injection, based on patient experience and satisfaction questionnaires fielded in the studies.

In addition, the studies were conducted using Enable Injections’ enFuse hands-free OBI, an automated injector designed to deliver subcutaneously high-volume medicines beginning with the push of a button, to administer Sarclisa SC formulation.

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Related Topics and Keywords

multiple myeloma, Sanofi, Sanofi’s Sarclisa, Sarclisa®