Posted by Michael Wonder on 20 Apr 2021
Amgen's investigational targeted treatment bemarituzumab granted breakthrough therapy designation
19 April 2021 - Designation is supported by results from the Phase 2 FIGHT trial.
Amgen today announced that the U.S. FDA granted breakthrough therapy designation for investigational bemarituzumab as first-line treatment for patients with fibroblast growth factor receptor 2b (FGFR2b) overexpressing and human epidermal growth factor receptor 2 (HER2)-negative metastatic and locally advanced gastric and gastro-esophageal adenocarcinoma in combination with modified FOLFOX6 (fluoropyrimidine, leucovorin, and oxaliplatin), based on an FDA-approved companion diagnostic assay showing at least 10% of tumour cells overexpressing FGFR2b.
