FDA grants breakthrough therapy designation to RC48 for urothelial cancer
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The FDA granted breakthrough therapy designation to disitamab vedotin for treatment of certain patients with urothelial cancer, according to the agent’s manufacturer.
The designation applies to use of disitamab vedotin (RC48, RemeGen Co. Ltd.) — a novel humanized anti-HER2 antibody-drug conjugate — by patients with HER2-positive locally advanced or metastatic disease who previously received platinum-containing chemotherapy.
The FDA previously granted fast track designation to disitamab vedotin and cleared an investigational new drug application for a phase 2 study of the agent in the United States.
An estimated 81,400 new cases of urothelial cancer will be diagnosed in the U.S. this year, and approximately 17,980 people will die of the disease, according to American Cancer Society.
“The high prevalence of metastatic urothelial cancer underscores the need for effective and accessible treatment methods for patients,” Jianmin Fang, PhD, founder, CEO and chief scientific officer of RemeGen, said in a company-issued press release. “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.”
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