FDA Grants Fast Track Designation to 9MW2821 for the Treatment of Patients with Locally Advanced or Metastatic Nectin-4 Positive TNBC

CAR-T Digest - August 2020

Weekly Digest - July 2024

12 July 2024: FDA Grants Fast Track Designation to 9MW2821 for the Treatment of Patients with Locally Advanced or Metastatic Nectin-4 Positive TNBC

Mabwell’s 9MW2821, an innovative Nectin-4-targeting ADC, has received Fast Track Designation from the FDA
The Fast Track Designation applies to 9MW2821 for the treatment of locally advanced or metastatic Nectin-4 positive triple-negative breast cancer (TNBC)
9MW2821 has also been granted Fast Track Designation for advanced, recurrent, or metastatic oesophageal squamous cell carcinoma (ESCC) and recurrent or metastatic cervical cancer (CC)
Additionally, 9MW2821 has received Orphan Drug Designation for oesophageal cancer (EC)