FDA grants bemarituzumab breakthrough therapy designation (BTD) for first-line treatment of patients with FGFR2b overexpressing and HER2-negative metastatic and locally advanced gastric and gastroesophageal cancer

BTD has been granted for this IgG1 monoclonal antibody that selectively binds to FGFR2b, in combination with modified FOLFOX6 (fluoropyrimidine, leucovorin, and oxaliplatin), based on an FDA-approved companion diagnostic test showing ≥10% of tumour cells overexpressing FGFR2b.

Source:

PharmaTimes