The United States Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to China-based RemeGen Co Ltd's disitamab vedotin (RC48), a novel humanised anti-HER2 antibody drug conjugate, intended for the second-line treatment of patients with HER2 positive locally advanced or metastatic urothelial cancer who have also earlier received platinum-containing chemotherapy treatment, it was reported on Friday.

The US FDA had earlier approved an Investigational New Drug (IND) application for a Phase II clinical study in the United States and the grant of Fast Track designation for the product.

Jianmin Fang, PhD. RemeGen founder, CEO and CSO, said, 'An estimated 81,400 new cases of urothelial cancer and 17,980 deaths are predicted in the United States in 2020. The high prevalence of metastatic urothelial cancer underscores the need for effective and accessible treatment methods for patients. This Breakthrough Therapy designation will bring RemeGen one step closer to finding a safe and effective treatment for this devastating disease. We look forward to working with the FDA to advance the clinical development of disitamab vedotin.'