ALPHAMAB-B: JSKN003 has been granted FTD by the U.S. FDA for the treatment of PROC
ALPHAMAB-B announced that its drug JSKN003 has received Fast Track Designation (FTD) from the U.S. FDA for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. This milestone marks the progress of JSKN003's global development. In addition, JSKN003 has also received approval for Phase II clinical trials and has been granted Breakthrough Therapy Designation for PROC and colorectal cancer. The Phase III clinical trial of the drug is progressing smoothly in China
According to the Zhitong Finance APP, ALPHAMAB-B (09966) announced that JSKN003 has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (collectively referred to as PROC) regardless of human epidermal growth factor receptor 2 (HER2) expression levels. This marks another important milestone in the global development process of JSKN003.
In addition, JSKN003 has received FDA approval to conduct a Phase II clinical trial for PROC regardless of HER2 expression levels, and has been granted Breakthrough Therapy Designation by the National Medical Products Administration (NMPA) for both PROC and colorectal cancer (CRC), as well as Orphan Drug Designation by the FDA for gastric/gastroesophageal junction cancer (GC/GEJ). Furthermore, the Phase III clinical trial of JSKN003 for PROC regardless of HER2 expression levels is progressing smoothly in China. The granting of FTD further underscores the confidence of international regulatory agencies in the clinical potential of JSKN003 and its importance as a novel therapeutic candidate
