JSKN003 was granted Breakthrough Therapy Designation by the FDA for the treatment of PROC

CAR-T Digest - August 2020

Weekly Digest - December 2025

18 December 2025: JSKN003 was granted Breakthrough Therapy Designation by the FDA for the treatment of PROC

Alphamab Oncology announced that the U.S. FDA has granted Breakthrough Therapy Designation to JSKN003 for the treatment of adult patients with advanced or metastatic platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal, or fallopian tube cancers expressing HER2, who have previously received bevacizumab
The Breakthrough Therapy Designation is based on pooled efficacy and safety data from Phase 1 and Phase 1/2 studies conducted in Australia and China, which were presented at the 2025 ASCO Annual Meeting, and is expected to accelerate the clinical development and regulatory review of JSKN003 globally
This latest designation builds on a strong regulatory foundation for JSKN003, which has already received FDA clearance to initiate a Phase 2 study in PROC, Fast Track Designation from the FDA for PROC, multiple Breakthrough Therapy Designations from China’s NMPA for PROC and colorectal cancer, and Orphan Drug Designation from the FDA for gastric and gastroesophageal junction cancers
The FDA’s decision reflects growing confidence in the clinical potential of JSKN003, particularly in a disease setting where patients face limited treatment options, high recurrence rates, and poor long-term outcomes
For patients with platinum-resistant ovarian cancer, current non-platinum chemotherapy options deliver modest benefit, with low response rates, short progression-free survival, and median overall survival of roughly one year, underscoring the urgent need for more effective therapies