FDA awards Disitamab Vedotin (RC48) "breakthrough therapy" for the treatment of urinary endocrine cell carcinoma

The most common form of urinary tract cancer is urinary cortectal cell carcinoma, which used to be called a type-shifting cortectal cell carcinoma.
urinary tract epithelials are widely found in the kidneys, ureter, bladder and urethra.
Pharmaceutical Company RemeGen announced today that the U.S. Food and Drug Administration (FDA) has awarded the new humanized anti-HER2 antibody drug co-ed (ADC) Disitamab Vedotin (RC48) the "breakthrough therapy title."
Disitamab Vedotin (RC48) is expected to be used as a second-line therapy for HER2-positive patients with localized advanced or metastatic genitourinary endocrine cell carcinoma (UC), who have previously received chemotherapy with platinum.
, RemeGen announced that the FDA had approved a new research drug (IND) application for Phase II clinical studies in the United States and awarded Disitamab vedotin the fast-track title.
RemeGen CEO and Chief Operating Officer, Dr. Jianmin Fang said, "By 2020, there are expected to be 81,400 new cases of urinary endocrine cell carcinoma and 17,980 deaths in the United States.
high prevalence of metastatic genitourinary cell carcinoma highlights medical needs.
We look forward to working with the FDA to promote the clinical development of Disitamab Vedotin."
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