Posted by Michael Wonder on 20 Dec 2025
Alphamab Oncology announces biparatopic HER2 targeting ADC JSKN003 was granted breakthrough therapy designation by the FDA for the Treatment of PROC
20 December 2025 - Alphamab Oncology announced that the biparatopic HER2-targeting antibody drug conjugate JSKN003, independently by the US FDA for the treatment of adult patients with advanced or metastatic platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal, or fallopian tube cancers expressing HER2 (IHC 1+, 2+ and 3+) who have received prior treatment with bevacizumab.
Previously, JSKN003 has received approval from FDA to initiate a Phase 2 clinical study for the treatment of PROC not restricted by HER2 expression, has been granted fast track designation by the FDA for platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal, or fallopian tube cancers and has been granted orphan drug designation by the FDA for gastric cancer and gastro-oesophageal junction cancer.
