French drug major Sanofi (SNY) announced Monday that its Sarclisa has obtained first approval in China for the treatment of adult patients with relapsed or refractory multiple myeloma or R/R MM.
The National Medical Products Administration or NMPA in China has approved Sarclisa, an anti-CD38 medicine, in combination with pomalidomide and dexamethasone or Pd to treat multiple myeloma or MM in adult patients, who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor.
Sarclisa (isatuximab) is a CD38 monoclonal antibody that binds to a specific epitope on the CD38 receptor on MM cells, inducing distinct antitumor activity.
The approval is based on results from the pivotal ICARIA-MM phase 3 study, using the China-based IsaFiRsT real-world study as bridging data.
The ICARIA-MM study demonstrated Sarclisa in combination with Pd significantly reduced the risk of disease progression or death by 40%, and resulted in a clinically meaningful, 6.9-month improvement in overall survival, compared to Pd alone.
In addition, the IsaFiRsT study, which is the first real-world study for the registration of an anti-CD38 therapy in combination with Pd in China, showed an overall response rate or ORR of 82.6% among R/R MM adult patients.
Olivier Nataf Global Head, Oncology, said, "This approval marks an important milestone for Sanofi in China. The results of the ICARIA-MM phase 3 study, coupled with the real-world IsaFiRsT study, highlight the benefit of Sarclisa for patients living with multiple myeloma and the importance of innovative regulatory pathways for timely access to different treatments."
In addition to the NMPA approval, the Chinese Society of Clinical Oncology or CSCO and Chinese Anti-Cancer Association or CACA guidelines include Sarclisa-Pd as a "Category I Recommendation" and the "Preferred Option" for the treatment of patients with first-relapsed MM.
The company noted that a regulatory submission for Sarclisa in combination with bortezomib, lenalidomide and dexamethasone or VRd for newly diagnosed multiple myeloma (NDMM) in adult patients not eligible for autologous stem cell transplant, is also under review in China. A final decision is expected in the coming months.
In the US, the non-proprietary name for Sarclisa is isatuximab-irfc, with irfc as the suffix designated in accordance with nonproprietary naming of biological products guidance for industry issued by the US FDA.
Currently, Sarclisa is approved in more than 50 countries, including the US and EU, across two indications. Sarclisa is approved under an additional indication in the US.
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