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FDA Grants Fast Track Designation to Leronlimab for Metastatic TNBC

Gina Columbus @ginacolumbusonc
Published: Tuesday, May 07, 2019

Richard Pestell, MD, PhD

Richard Pestell, MD, PhD

The FDA has granted a fast track designation to the CCR5 antagonist leronlimab (PRO140) for use in combination with carboplatin for the treatment of patients with CCR5-positive metastatic triple-negative breast cancer (TNBC).

A phase II trial with leronlimab is being conducted to determine whether CCR5 receptor on engrafted cells is necessary for the development of acute GVHD and, by blocking it, researchers could recognize that select immune signaling molecules is a viable approach to mitigating acute GVHD. The FDA also granted an orphan drug designation to leronlimab as a prevention method of GVHD.
FDA Grants CytoDyn Fast Track Designation for Leronlimab (PRO 140) in metastatic Triple-Negative Breast Cancer, an Unmet Medical Need. CytoDon. Published May 7, 2019. Accessed May 7, 2019.

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