Sanofi's Sarclisa Approved in China for Relapsed or Refractory Multiple Myeloma
China's NMPA has approved Sanofi's Sarclisa (isatuximab) in combination with pomalidomide and dexamethasone for adult patients with relapsed or refractory multiple myeloma. The approval utilized pivotal trial data and real-world evidence from China.
Paris, France – Sanofi announced that its anti-CD38 therapy, Sarclisa (isatuximab), has received its first approval in China from the National Medical Products Administration (NMPA). The drug will be used in combination with pomalidomide and dexamethasone (Pd) for adult patients suffering from relapsed or refractory multiple myeloma who have previously undergone at least one line of therapy, including lenalidomide and a proteasome inhibitor.
The NMPA's decision was informed by the pivotal ICARIA-MM phase 3 study, augmented by bridging data from the China-based IsaFiRsT real-world study. The ICARIA-MM trial demonstrated that Sarclisa plus Pd significantly reduced the risk of disease progression or death by 40% and provided a clinically meaningful improvement in overall survival compared to Pd alone. The IsaFiRsT study, notable as the first real-world study for an anti-CD38 therapy in combination with Pd in China, reported an overall response rate (ORR) of 82.6% in adult patients.
This approval marks a significant milestone for Sanofi in China, highlighting the increasing use of real-world evidence (RWE) by regulatory bodies to expedite the review of innovative therapies. Sarclisa is the first blood cancer treatment approved in China based on RWE in addition to clinical trial data. This regulatory pathway was enabled by the Lecheng Pilot program facilitating the use of real-world data.
Further extending its applicability, Sanofi has a pending regulatory submission in China for Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for newly diagnosed multiple myeloma patients ineligible for autologous stem cell transplant.