RemeGen’s Disitamab Vedotin (RC48) Receives the US FDA’s Breakthrough Therapy Designation for Urothelial Cancer
Shots:
- The US FDA has granted BTD for disitamab vedotin (RC48) for 2L treatment patients with HER2+ LA/m-UC who had prior received Pt-containing CT treatment
- Earlier, RemeGen reported the FDA’s clearance of an IND application for a P-II clinical study in the US and the grant of FTD for disitamab vedotin
- RC48 is a novel humanized anti-HER2 ADC, currently being studied in multiple late-stage clinical trials across solid tumor types
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