Amgen's innovative first-line therapy for gastric cancer, bemarituzumab, is recognized by the U.S. FDA as a breakthrough therapy

Today, Amgen announced that its under-development FGFR2b antibody therapy bemarituzumab has been certified as a breakthrough therapy by the U.

Gastric carcinoma (gastric carcinoma) is a malignant tumor that originates from the epithelium of the gastric mucosa, and ranks first in the incidence of various malignant tumors in my country.

It is reported that as early as December 2017, Five Prime Therapeutics granted Zai Lab an exclusive license to develop and commercialize bemarituzumab in Greater China.

It is worth mentioning that the antibody therapy bemarituzumab is Amgen's second product to be certified as a breakthrough therapy in the past six months after Sotorasib (AMG 510), the first drug targeting the KRAS G12C mutation.

It is reported that the award of the breakthrough therapy designation is based on the positive results of a phase 2 clinical trial called FIGHt, and this trial is the first study to evaluate FGFR2b overexpression in targeted tumors.

Clinical results show that the combination of bemarituzumab and chemotherapy can significantly improve the progression-free survival and overall survival of patients in at least 10% of tumor cells overexpressing FGFR2b, and the clinical benefit is related to the proportion of FGFR2b-positive tumor cells There is a positive correlation.

In the future, it is expected that Amgen will further study the role of FGFR2b and continue to cooperate with regulatory agencies to bring this potential first-in-class first-line therapy to patients.