French pharmaceutical major Sanofi (NASDAQ: SNY) has announced import approval in Shenzhen via the Greater Bay Area special drug entry scheme for its CD38 monoclonal antibody (mAb) Sarclisa (isatuximab). The approval covers Sarclisa in combination with pomalidomide plus dexamethasone for the treatment of multiple myeloma (MM) in patients who have previously received at least two lines of treatment. Additionally, it is approved in combination with carfilzomib plus dexamethasone for recurrent or refractory MM in patients who have previously received 1 to 3 lines of treatment.
Sarclisa: First Therapy via Greater Bay Area Green Channel
Sarclisa is the first MM therapy introduced via the Guangdong-Hong Kong-Macao Greater Bay Area (GBA) drug and device special green channel. It is also one of only two blood cancer therapies on the list. This approval highlights the innovative approach of the GBA in facilitating access to novel therapies for patients in need.
Clinical Trial Results
The global Phase III IKEMA study demonstrated that, compared to the treatment group with carfilzomib and dexamethasone (Kd), the progression-free survival (PFS) of patients treated with Sarclisa combined with Kd was 35.7 months, reducing the risk of recurrence and death by 42% and significantly improving the depth of remission in patients with relapsed refractory multiple myeloma (≥ 44.1% complete remission rate). Data from the Phase III ICARIA-MM study showed that the combination of Sarclisa significantly prolonged PFS (median PFS: 11.53 months vs. 6.47 months; HR=0.596, 95% CI: 0.44-0.84, P=0.001) and significantly improved the overall response rate (ORR: 60.4% vs. 35.3%, P<0.0001) compared to the treatment group of pomalidomide and dexamethasone.
Regulatory and Development Milestones
Sarclisa was first approved in the US in March 2020 for the treatment of MM and obtained a second approval in April 2021 for use in recurrent or refractory MM that has received 1-3 line treatments in the past combined with Kd. Meanwhile, multiple Phase III clinical studies are underway assessing the drug in MM, alongside ongoing trials in other blood cancers and solid tumors.
Strategic Implications
The import approval of Sarclisa in Shenzhen via the Greater Bay Area scheme underscores Sanofi’s commitment to making innovative treatments available to patients in China. This move is expected to enhance the treatment options for patients with multiple myeloma and further solidify Sanofi’s position in the global oncology market.-Fineline Info & Tech
