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Amgen stomach cancer drug awarded Breakthrough Therapy Designation

Published on 21/04/21 at 11:57am
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Amgen’s investigational therapy, bemarituzumab, for certain types of stomach and esophagus cancer, has been granted Breakthrough Therapy Designation by the FDA.

Amgen acquired Five Prime Therapeutics, and with it the Phase III-ready bemarituzumab, last week for $1.9 billion.

A Breakthrough Therapy Designation is designed to expedite the development and regulatory review of medicines that may demonstrate substantial improvement on a clinically significant endpoint over available medicines.

Bemarituzumab could be a first-line treatment for patients with metastatic and locally advanced gastric and gastroesophageal (GEJ) adenocarcinoma, in combination with modified FOLFOX6 (fluoropyrimidine, leucovorin, and oxaliplatin).

The designation is supported from results of the Phase II FIGHT trial, which evaluated bemarituzumab plus chemotherapy versus chemotherapy alone in patients with frontline advanced gastric or GEJ cancer.

The study showed treatment with bemarituzumab plus chemotherapy demonstrated clinically significant improvements in progression-free survival and overall survival in patients with at least 10% of tumor cells over-expressed Fibroblast Growth Factor Receptor 2b (FGFR2b).

Bemarituzumab  is designed to block fibroblast growth factors from binding and activating FGFR2b, inhibiting several downstream pro-tumour signalling pathways, and potentially slowing cancer progression.

More than one million new gastric cancer cases are diagnosed annually, with gastric cancer particularly prevalent in Asia. Around 25% of patients with advanced gastric and GEJ cancers present with FGFR2b over-expression, due to being HER2-negative.

Dr David M Reese, Executive Vice President of Research and Development at Amgen, said: ”The FIGHT trial is the first study to evaluate targeting the over-expression of FGFR2b in cancer. Bemarituzumab demonstrated clinically meaningful outcomes in key endpoints for patients with advanced gastric or gastroesophageal cancer as a frontline therapy.

"Amgen looks forward to further investigating the role of FGFR2b and will continue to work with regulatory agencies on next steps to bring this potential first-in-class, frontline therapy to patients.”

Jack Goddard

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