The US Food and Drug Administration (FDA) has approved Sanofi’s anti-CD38 monoclonal antibody isatuximab-irfc (Sarclisa) for newly diagnosed multiple myeloma.

It is approved in combination with bortezomib, lenalidomide, and dexamethasone for adults with who are not eligible for autologous stem cell transplant (ASCT).

The efficacy of the treatment was evaluated in the IMROZ trial in patients with newly diagnosed multiple myeloma who were not eligible for ASCT.

The main efficacy outcome measure was progression-free survival (PFS) as assessed by an independent review committee based on International Myeloma Working Group criteria. IMROZ demonstrated an improvement in PFS with a 40% reduction in risk of disease progression or death.

Thomas Martin, Helen Diller Family Comprehensive Cancer Center Clinical Professor of Medicine at the University of California San Francisco, commented: “Multiple myeloma is most frequently diagnosed in patients 65 years and older, yet the options for treatment in this population are limited due to a combination of age, frailty, and co-morbidities. The significant clinical benefit and improvements in progression-free survival demonstrated by the IMROZ regimen of isatuximab plus VRd versus VRd alone make today’s approval an important moment for this vulnerable patient population and the larger multiple myeloma community.”

Sarclisa binds to a specific epitope on the CD38 receptor on MM cells, inducing distinct antitumor activity. It is designed to work through multiple mechanisms of action including programmed tumour cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on the surface of MM cells, making it a target for antibody-based therapeutics such as Sarclisa.

The FDA’s decision marks the third approved indication for Sarclisa in the US and the first approved indication in newly diagnosed patients. The therapy is also currently approved in more than 50 countries across two indications for the treatment of people with relapsed or refractory disease.

Diana Spencer, Senior Digital Content Editor, DDW