Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team
- Jul 21
- 1 min read
17/07/2026
China NMPA grants approval to iza‑bren, delivering survival benefit in recurrent/metastatic ESCC after PD‑1/PD‑L1 therapy (Ref)
China’s NMPA approved Biokin Pharma's iza-bren (izalontamab brengitecan; EGFR x HER3 bispecific ADC) for recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after progression on platinum-based chemotherapy and PD-1/PD-L1 therapy
This is iza-bren’s second approval in China, following nasopharyngeal carcinoma, reinforcing its role as a first-in-class EGFR × HER3 bispecific ADC
Approval was supported by the PANKU-Esophagus01 (BL-B01D1-305) Phase 3 trial, which showed:
Median OS: 9.8 months vs 7.2 months with chemotherapy (HR=0.64, p=0.0004)
Median PFS: 4.2 months vs 2.0 months (HR=0.50, p<0.0001)
Low discontinuation (2%) and manageable safety profile
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