Posted by Michael Wonder on 26 Sep 2020
RemeGen announces US FDA has granted breakthrough therapy designation for disitamab vedotin (RC48) in urothelial cancer
25 September 2020 - RemeGen today announced that the U.S. FDA has granted Breakthrough Therapy designation for disitamab vedotin (RC48), a novel humanised anti-HER2 antibody drug conjugate, for the second-line treatment of patients with HER2 positive locally advanced or metastatic urothelial cancer who have also previously received platinum-containing chemotherapy treatment.
Earlier this year, RemeGen announced the FDA's clearance of an investigational new drug application for a Phase 2 clinical study in the United States and the grant of fast track designation for disitamab vedotin.
RC48 was developed to treat HER2 expressing solid tumours.
