SystImmune Announces Second Approval of Iza-bren in China for the Treatment of Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
Regulatory approval for izalontamab brengitecan (iza-bren) in adult patients with recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after platinum‑based chemotherapy and PD‑1/PD‑L1 therapy, based on a phase 3 randomized trial demonstrating clinically significant improvements in progression‑free survival and overall survival versus investigator‑chosen chemotherapy.
The Chinese NMPA has approved izalontamab brengitecan (iza‑bren) for the treatment of adult patients with recurrent or metastatic esophageal squamous cell carcinoma (ESCC) who progressed after prior platinum‑based chemotherapy and PD‑1/PD‑L1 inhibitor therapy. The approval follows results from the phase 3 PANKU‑Esophagus01 (BL‑B01D1‑305) trial, which showed statistically significant and clinically meaningful improvements in median overall survival (9.8 vs 7.2 months) and median progression‑free survival (4.2 vs 2.0 months) versus chemotherapy, with a manageable safety profile.
ESCC remains a lethal disease with limited second‑line options; the approval of izan‑bren offers a novel therapeutic with improved survival and tolerable safety, addressing a critical unmet need.
Bizonyítékszint: Számítógépes vagy elméleti. Modellből vagy adatbányászatból származó jel.
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