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  • Bemarituzumab is granted ODD status in Korea
  • by Eo, Yun-Ho | translator Kim, Jung-Ju | Dec 7, 2023 05:47am
Amgen's new gastic cancer drug
MFDS grants orphan drug designation status¡¦first-in-class FGFR2b targeted antibody medicine
FIGHT phase 2 trials show promising results¡¦results from phase 3 trials to be watched
The new gastric cancer drug bemarituzumab received an orphan drug status in Korea.

The Ministry of Food and Drug Safety (MFDS) recently announced so through the orphan drug designation notice. Specifically, the drug is indicated to treat patients with fibroblast growth factor receptor 2b (FGFR2b) overexpression and unresectable locally advanced or metastatic gastric or GEJ adenocarcinoma.

Amgen¡¯s bemarituzumab is a first-in-class investigational FGFR2b targeted antibody. And, Amgen gained access to the drug as part of its acquisition of Five Prime Therapeutics in 2021. In the same year, the FDA has granted bermarituzumab a Breakthrough Therapy designation (BTD).

Bermarituzumab is a humanized IgG1 monoclonal
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