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FDA grants fast track designation to balixafortide for metastatic breast cancer

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The FDA granted fast track designation to balixafortide in combination with eribulin for the treatment of patients with HER-2-negative metastatic breast cancer who failed at least two prior chemotherapy regimens.

Balixafortide (POL6326, Polyphor) is a highly selective CXCR4 antagonist.

The combination of balixafortide and eribulin (Halaven, Eisai) demonstrated activity in a phase 1b proof-of-concept trial that included patients with metastatic breast cancer, according to a Polyphor-issued press release.

“We have already identified a development path for balixafortide with input from the FDA to conduct a single pivotal study in this indication,” Giacomo Di Nepi, CEO of Polyphor, said in the release. “Fast track designation is another positive step for the development of balixafortide and a recognition of the need for better treatments for this group of patients.”

The pivotal trial will evaluate balixafortide in combination with eribulin for the treatment of patients with HER-2-negative breast cancer who have received at least two prior chemotherapeutic regimens in the metastatic setting.