China’s NMPA Approves Sarclisa For Relapsed Multiple Myeloma Treatment

China's National Medical Products Administration (NMPA) has approved Sarclisa, an anti-CD38 monoclonal antibody. The drug is to be used in combination with pomalidomide and dexamethasone (Pd) to treat adults with multiple myeloma (MM). The treatment benefits patients who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor. Sanofi is one of the country's first multinational pharmaceutical companies to remain dedicated to advancing innovative medicines and vaccines. With the approval of Sarclisa, Sanofi aims to enhance treatment options and improve outcomes for Chinese patients with multiple myeloma.

This approval is supported by data from the ICARIA-MM phase 3 study and the China-based IsaFiRsT real-world study. The ICARIA-MM trial showed that adding Sarclisa to Pd reduced the risk of disease progression or death by 40% and improved overall survival (OS) by an average of 6.9 months, compared to Pd alone. The IsaFiRsT study further reinforced these findings, with an overall response rate (ORR) of 82.6% among relapsed or refractory multiple myeloma patients in real-world settings.

Olivier Nataf, Global Head of Oncology, said in a statement, “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. We look forward to continuing to build strong partnerships with the medical community, local companies, and authorities in China as we work to bring more innovative treatments to patients.” 

The NMPA’s decision reflects a growing reliance on real-world evidence (RWE) in China, facilitated by the Lecheng Pilot program, to accelerate the review and approval of innovative treatments. Sarclisa is an innovator, being one of the first therapies authorised for real-world studies under the pilot program and the first blood cancer treatment approved in China using clinical and real-world data.

Sarclisa-Pd has also earned a "Category I Recommendation" and is designated as the "Preferred Option" for treating first-relapsed MM in guidelines issued by the Chinese Society of Clinical Oncology (CSCO) and the Chinese Anti-Cancer Association (CACA). Meanwhile, a regulatory review is underway for Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for treating newly diagnosed multiple myeloma (NDMM) patients who are ineligible for autologous stem cell transplants, with a decision expected soon.