First in class gastric cancer first-line therapy won CDE plans to break through treatment Zai Lab owns Chinese rights

Author: Sunshine

On September 3, the CDE official website revealed that Amgen’s FPA144 injection (bemarituzumab) is intended to be included in the breakthrough treatment product, and combined with mFOLFOX6 (fluorouracil, leucovorin and oxaliplatin) for the first-line treatment of FGFR2b overexpression (immunohistochemistry) The method detects at least 10% of tumor cells overexpressing FGFR2b), human epidermal growth factor receptor (HER2) negative locally advanced or metastatic gastric and gastroesophageal junction cancer (GEJ) patients

Gastric cancer is the third most common cancer in the world, and it is also the fifth most common cancer in the world other than non-melanoma skin cancer.

Bemarituzumab is an isoform-selective monoclonal antibody targeting FGFR2

bemarituzumab mechanism of action

Bemarituzumab was originally developed by Five Prime.

In November 2020, Five Prime announced the data of a Phase II clinical FIGHT study for the first-line treatment of gastric and gastroesophageal junction cancer (GEJ)

The results showed that the median progression-free survival (PFS) of the bemarituzumab group was 2.

In June 2021, Zai Lab announced the latest research data of the phase II clinical trial of bemarituzumab at the ASCO meeting