RemeGen’s Disitamab Vedotin (RC48) Receives the US FDA’s Breakthrough Therapy Designation for Urothelial Cancer

 RemeGen’s Disitamab Vedotin (RC48) Receives the US FDA’s Breakthrough Therapy Designation for Urothelial Cancer

Roche’s Tecentriq Based Combination Therapy Receives EC’s Approval as 1L Treatment for Non-Squamous Non-Small Cell Lung 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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