MHRA approves SARCLISA for newly diagnosed multiple myeloma

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for SARCLISA (isatuximab), making it the first and only anti-CD38 quadruplet therapy available for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). This decision provides a new first-line treatment option for thousands of patients in the UK facing this blood cancer.

A significant advancement for multiple myeloma patients

The MHRA’s approval is based on results from the Phase III IMROZ trial, which showed that adding SARCLISA to the current standard treatment significantly improved progression-free survival (PFS), reducing the risk of disease progression or death by 40 percent compared to standard therapy alone.

This marks a major breakthrough for patients who are not eligible for stem cell transplantation, a common but intensive treatment approach for younger or fitter multiple myeloma patients. Results from this trial were published in the New England Journal of Medicine. The biologic has also been studied as a combination treatment with carfilzomib and dexamethasone (Kd).

Commenting on the approval, Anju Bhalla, Head of oncology and haematology at Sanofi UK and Ireland, highlighted the urgent need for new treatment options: “While significant strides have been made in multiple myeloma treatment, there is a continued unmet need for patients with this disease. Effective first-line treatment is essential in managing and delaying disease progression. [Following the MHRA’s] decision, patients across the UK are a step closer to accessing a new combination therapy that could significantly impact their treatment journey.”

How SARCLISA works

SARCLISA is a monoclonal antibody that targets CD38, a protein found on the surface of multiple myeloma cells. By binding to CD38, the drug triggers anti-tumour activity through multiple mechanisms, including immune system activation and programmed cell death. This targeted approach has been shown to enhance the effectiveness of existing treatments, helping to improve patient outcomes while maintaining a manageable safety profile.

Regulatory approval and NHS access

The MHRA’s decision follows similar approvals from the European Commission and the US Food and Drug Administration (FDA). The next step for UK patients is for the National Institute for Health and Care Excellence (NICE) to assess the treatment’s cost-effectiveness for use within the NHS. If approved, SARCLISA could soon become widely available as a new standard of care for transplant-ineligible multiple myeloma patients.

This approval marks a milestone in multiple myeloma treatment, offering a new hope for patients who require effective, first-line therapies to slow disease progression and improve quality of life.