Sanofi has received approval from the European Commission (EC) for the use of Sarclisa (isatuximab) with pomalidomide and dexamethasone (pom-dex) to treat adults with relapsed and refractory multiple myeloma (MM).
The indication for patients who had at least two previous therapies, including lenalidomide and a proteasome inhibitor, with disease progression on the last therapy.
Sarclisa is a monoclonal antibody (mAb) that attaches to a selective epitope on the CD38 receptor of MM cells, meant to stimulate programmed tumour cell death (apoptosis) and immunomodulatory activity.
Sanofi Research and Development global head John Reed said: “The EC approval of Sarclisa represents an important additional therapeutic option and may set a new standard of care for myeloma patients in Europe who are in need of new effective treatments because their disease has returned or they have become refractory to their previous treatment.
“Sarclisa in combination with pom-dex demonstrated median progression-free survival of nearly one year, a five-month improvement over pom-dex alone, in patients who had already failed at least two prior therapies.”
The approval comes after the Phase III ICARIA-MM clinical trial, where Sarclisa and pom-dex combination led to a statistically significant improvement of progression-free survival (PFS).
With the combination, the median PFS was 11.53 months versus 6.47 months with pom-dex alone. The combination also showed a significantly greater overall response rate compared to only pom-dex treatment.
Aside from in the European Union (EU), Sarclisa holds approval in the US, Switzerland, Canada and Australia for use with pom-dex to treat some adults with relapsed refractory MM.
Currently, Sarclisa is being studied in various Phase III clinical in combination with current standard treatments for MM. Sanofi is also assessing the drug for other haematologic malignancies and solid tumours.
In April, Sanofi and GlaxoSmithKline (GSK) signed a letter of intent for a partnership to develop an adjuvanted vaccine for Covid-19.