Posted by Michael Wonder on 29 Oct 2025
Alphamab Oncology announces biparatopic HER2 targeting ADC JSKN003 was granted fast track designation by FDA for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
28 October 2025 - Alphamab Oncology announced that the biparatopic HER2-targeting antibody drug conjugate JSKN003 has been granted fast track designation by the US FDA for the treatment of advanced or metastatic platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (PROC), not restricted by HER2 expression.
This marks another accelerated review recognition for JSKN003 from an internationally authoritative regulatory agency, following two previous breakthrough therapy designations from the National Medical Products Administration for both PROC and colorectal cancer and an orphan drug designation from the FDA for gastric cancer/gastro-oesophageal junction cancer this year.
