Shots:
- The conditional approval is based on the SIOPEN trial evaluating dinutuximab beta vs dinutuximab beta with/out IL-2 in 514 patients aged ≥12 mos. with high-risk neuroblastoma who have received induction CT & partial response along with a history of R/R neuroblastoma with/out the residual disease. The trial was conducted by SIOPEN in collaboration with Apeiron & EUSA
- The results also demonstrated the 5yrs. EFS rate (57% vs 42%) and OS rate (64% vs 50%). The safety of the therapy was also evaluated
- Qarziba is a mAb targeting carbohydrate moiety of disialoganglioside 2 (GD2) & has received the EC’s approval for the same indication in 2017
Click here to read full press release/ article | Ref: BeiGene | Image: SybBioBeta
The post BeiGene and EUSA Receive the NMPA’s Approval of Qarziba (dinutuximab beta) for High-Risk Neuroblastoma first appeared on PharmaShots.
