Currently, the therapy available through our single-patient expanded access (EA) program is JSKN003 , intended for the treatment of adult patients with advanced or metastatic platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer expressing HER2 (IHC 1+/2+/3+) who have received prior treatment with bevacizumab.
Consistent with U.S. FDA’s guidelines, expanded access may be appropriate when all the following apply:
• Patient has a serious or immediately life-threatening disease or condition.
• There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
• Patient enrollment in a clinical trial is not possible.
• Potential patient benefit justifies the potential risks of treatment.
• Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.