Amgen’s investigational medicine bemarituzumab has received a breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA).
The FDA has granted bemarituzumab a BTD for the first-line treatment of patients with fibroblast growth factor receptor 2b (FGFR2b) overexpressing and human epidermal growth factor receptor 2 (HER2)-negative metastatic and locally advanced gastric and gastroesophageal (GEJ) cancer.
The BTD has been granted for bemarituzumab as a treatment for these patients when used in combination with modified FOLFOX6 (fluoropyrimidine, leucovorin, and oxaliplatin), based on an FDA-approved companion diagnostic test showing at least 10% of tumour cells overexpressing FGFR2b.
This is supported by the Phase II FIGHT trial, which evaluated bemarituzumab plus chemotherapy versus chemotherapy alone in patients with FGFR2b-positive, non-HER2 positive frontline advanced gastric or GEJ cancer.
In this trial, bemarituzumab treatment plus chemotherapy demonstrated clinically significant and substantial improvements in progression-free survival and overall survival in the patient population with at least 10% of tumour cells overexpressing FGFR2b.
Further analysis found a positive correlation between benefit and the prevalence of FGFR2b+ tumour cells.
The BTD was granted based upon the subset of patients who showed at least 10% of tumour cells overexpressing FGFR2b+.
“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,” said David Reese, executive vice president of research and development at Amgen.
Amgen gained access to bemarituzumab as part of its acquisition of Five Prime Therapeutics earlier this year.
“Five Prime fits squarely within Amgen’s leading oncology portfolio and includes bemarituzumab, a Phase III trial-ready, first-in-class program for gastric cancer, the third leading cause of cancer mortality worldwide,” said Robert Bradway, chairman and chief executive officer of Amgen.
“Working with the dedicated professionals joining us from Five Prime, we plan to quickly move bemarituzumab into a Phase III study, bringing it one step closer to helping patients suffering from gastric cancer,” he added.