BeiGene's Pediatric Tumor Drug Scores Conditional Approval In China
- The China National Medical Products Administration (NMPA) granted conditional approval for BeiGene Ltd (NASDAQ: BGNE) - EUSA Pharma's (UK) Qarziba (dinutuximab beta) in high-risk neuroblastoma patients.
- The approval comes for patients aged 12 months and above who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation.
- Related content: Benzinga's Full FDA Calendar.
- Dinutuximab beta is targeted immunotherapy approved by the European Medicines Agency.
- The approval of dinutuximab beta in China is based on SIOPEN trial data in 514 patients.
- The five-year event-free survival rate in the dinutuximab arm was 57% vs. 42% of historical controls in the trial.
- The five-year overall survival (OS) rate was 64% vs. 50%.
- Price Action: BGNE shares are up 0.34% at $81.52 during the market session on the last check Tuesday.
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