Amgen's Bemarituzumab Scores Breakthrough Therapy Tag For Gastric, GEJ Cancers

The FDA has granted Breakthrough Therapy Designation to Amgen Inc's (NASDAQ: AMGN) bemarituzumab for patients with gastric and gastroesophageal (GEJ) adenocarcinoma.
The designation covers bemarituzumab as first-line treatment of fibroblast growth factor receptor 2b, overexpressing and human epidermal growth factor receptor 2-negative, metastatic and locally advanced GEJ adenocarcinoma in combination with modified FOLFOX6 (fluoropyrimidine, leucovorin, and oxaliplatin).
Following sotorasib, bemarituzumab is the second asset in Amgen's oncology portfolio to receive Breakthrough Therapy Designation in the past six months.
The designation is designed to expedite the development and regulatory review of medicines that may demonstrate substantial improvement on a clinically significant endpoint over available medications.
Bemarituzumab is a targeted antibody that is designed to block fibroblast growth factors from binding and activating FGFR2b, inhibiting several downstream pro-tumor signaling pathways and potentially slowing cancer progression.
Zai Lab Ltd (NASDAQ: ZLAB) was granted an exclusive license to develop and commercialize bemarituzumab in Greater China.
Price Action: AMGN shares closed 0.1% higher at $255.9 on Monday.