Sanofi’s Sarclisa approved by MHRA as UK’s first anti-cancer treatment given via on-body injector
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Sanofi's anti-CD38 monoclonal antibody Sarclisa has earned MHRA authorization for subcutaneous injection via an on-body injector or manual format. This regulatory milestone establishes a global first for automated, home-based administration within multiple myeloma oncology care pathways.
It is the first anticancer treatment in the UK and globally to be administered this way and a first in multiple myeloma. Sanofi’s Sarclisa (isatuximab) has been given marketing authorisation by the MHRA for subcutaneous (SC) use in combination with standard-of-care regimens to treat patients with multiple myeloma. Sarclisa is the first anti-cancer therapy in the UK that will provide the option of administration through an on-body injector (OBI) or standard manual SC injection, providing the potential flexibility of administration at patients’ homes and in the outpatient setting.
“Multiple myeloma is a complex disease that often requires repeated and prolonged clinic visits, placing a considerable burden on patients and those who support them. There has been a need for innovative approaches to ease this aspect of the treatment journey,” says Karthik Ramasamy, Professor of Haematology and Consultant Haematologist at Oxford University Hospital NHS Trust and Clinical Director of the Oxford Translational Myeloma Centre, University of Oxford.
Transforming Patient-Centred Healthcare
”The ability to administer a therapy through an on-body injector, particularly an anti-cancer drug, either in the clinic or eventually at a patient’s home, represents a meaningful step forward. With this option now approved, we have an opportunity to potentially reduce pressure on the NHS while placing greater flexibility and convenience at the heart of patient-centred care. This approach directly aligns with the NHS Ten Year Plan and National Cancer Plan to transform the healthcare system through technology and leveraging innovation.”
The approval of Sarclisa SC, which follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use, is based on the results from the pivotal IRAKLIA phase 3 study in relapsed/refractory, which demonstrated non-inferiority of the SC formulation compared to IV, as well as additional studies.
John Forni, Country Medical Lead, Sanofi UKIE, said: “This MHRA approval marks a pivotal moment for patients living with multiple myeloma in the UK. For the first time anywhere in the world, an anti-cancer therapy can be delivered through an on-body injector, and the UK is leading that charge. What excites me most is the real-world potential, an automated 13-minute median duration injection that can be administered at home or in the clinic, with favourable patient comfort and satisfaction. This is what patient-centred innovation looks like in practice.”
