Posted by Michael Wonder on 14 Sep 2022
TRACON Pharmaceuticals announces fast track designation by the FDA for envafolimab for the treatment of the soft tissue sarcoma subtypes of UPS and MFS
14 September 2022 - TRACON Pharmaceuticals announced today that the US FDA has granted fast track designation for the development of envafolimab (KN035) for patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma and myxofibrosarcoma who have progressed on one or two prior lines of chemotherapy.
Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology and licensed by TRACON, is the first approved subcutaneously injected PD-(L)1 inhibitor.
