Potential First-in-Class Therapy for a Subset of Gastric and Gastroesophageal Cancers That Overexpress Fibroblast Growth Factor Receptor 2 (FGFR2b)
Designation is Supported by Results From the Phase 2 FIGHT Trial
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (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 gastroesophageal (GEJ) adenocarcinoma in combination with modified FOLFOX6 (fluoropyrimidine, leucovorin, and oxaliplatin), based on an FDA-approved companion diagnostic assay showing at least 10% of tumor cells overexpressing FGFR2b.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.