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# Orphan Status for Mabwell Esophageal Cancer Drug
- URL: https://www.fdaweb.com/orphan-status-for-mabwell-esophageal-cancer-drug/
- Published: 2024-05-08T12:00:00.000Z
- Updated: 2026-09-14T14:30:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156947

FDA has granted China-based Mabwell an orphan drug designation for its novel Nectin-4-targeting antibody-drug conjugate 9MW2821 for treating esophageal cancer. The therapy was previously given a fast-track designation for treating advanced, recurrent, or metastatic esophageal squamous cell carcinoma. NECTIN-4 is an adhesion molecule expressed on various solid tumors, and 9MW2821 is designed to deliver monomethyl auristatin E to cells that express Nectin-4.

Multiple clinical studies involving 9MW2821 have been conducted in China to evaluate the drug’s safety, tolerability, pharmacokinetic characteristics, and efficacy in patients with various advanced solid tumors, the company says. A Phase 3 study of 9MW2821 as monotherapy has been initiated in patients with locally advanced or metastatic urothelial carcinoma who have previously received platinum-based chemotherapy and a PD-(L)1 inhibitor therapy. Also, it says a Phase 1-2 clinical study of the therapy in combination with PD-1 inhibitor Loqtorzi (toripalimab-tpzi) is ongoing in patients with locally advanced or metastatic urothelial cancer.