13 January 2025 - Approval based on positive pivotal ICARIA-MM Phase 3 study using the China-based IsaFiRsT real world study as bridging data, which demonstrated Sarclisa and the standard treatment pomalidomide and dexamethasone, improved responses and long-term outcomes compared to pomalidomide and dexamethasone alone in relapsed/refractory multiple myeloma patients.
The National Medical Products Administration in China has approved Sarclisa, an anti-CD38 medicine, in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor.