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FDA Grants Fast Track Designation for Balixafortide in Combination With Eribulin as Third-Line Therapy for Metastatic Breast Cancer

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On April 19, Polyphor announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for its novel immuno-oncology candidate balixafortide (POL6326) in combination with eribulin (Halaven) for the treatment of patients with HER2-negative metastatic breast cancer who previously received at least two chemotherapeutic regimens in the metastatic setting.

About Balixafortide

Balixafortide is a potent and highly selective antagonist of CXCR4, a G-protein coupled receptor that regulates the trafficking and homing of both cancer cells and cells of the patient's immune system. It is the only CXCR4 antagonist in development for breast cancer, and is the most advanced CXCR4 antagonist being developed in solid tumors.

CXCR4 plays a critical role in tumor growth, survival, angiogenesis, and metastasis. High CXCR4 levels have been detected in almost all human tumor types, including breast cancer. High CXCR4 expression is known to correlate with aggressive metastatic behavior of cancer cells and a poor prognosis.

Balixafortide showed strong results in a phase Ib/proof of concept clinical trial in combination with eribulin in patients affected with advanced metastatic breast cancer. The development path identified with the input of the FDA is to conduct a single pivotal study to achieve approval in HER2-negative metastatic breast cancer patients who previously received at least two chemotherapeutic regimens in the metastatic setting. Additionally, there is the possibility of achieving an accelerated conditional approval based on interim results.

Polyphor is also conducting preclinical work to establish the potential for balixafortide in combination with other drugs and in other oncology indications.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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