FDA has 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-negative metastatic and locally advanced gastric and gastroesophageal 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.
More than a year after a catastrophic shortage of platinum-based chemotherapy drugs swept through the U.S., FDA on June 28 officially removed carboplatin and cisplatin from the drug shortage list.
