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FDA grants fast track designation to leronlimab for metastatic triple-negative breast cancer
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The FDA granted fast track designation to leronlimab for use in combination with carboplatin for the treatment of patients with CCR5-positive metastatic triple-negative breast cancer.
Leronlimab (PRO 140, CytoDyn Inc.) is an investigational humanized IgG4 monoclonal antibody that blocks CCR5, a cellular receptor believed to play key roles in tumor invasion and metastasis.
Agents that block CCR5 have been shown to block tumor metastases in laboratory and animal models of aggressive breast cancer and prostate cancer.
“This [fast track designation] is an important acknowledgement of the potentially paradigm-shifting therapy option in metastatic triple-negative breast cancer,” Richard Pestell, MD, PhD, vice chairman and chief medical officer of CytoDyn, said in a company-issued press release. “Currently, there are no enduring treatment options for [patients with metastatic triple-negative breast cancer] and we thank the FDA for recognizing the potential of leronlimab [in this setting].”
Enrollment is underway for a study designed to evaluate the agent for patients with metastatic triple-negative breast cancer.
CytoDyn expects to submit a biologics license application to the FDA this year for leronlimab as part of combination therapy for patients with HIV.
The CCR5 receptor also may play a key role in modulating immune cell trafficking to sites of inflammation.
CytoDyn is conducting a phase 2 study of leronlimab to support the concept that the CCR5 receptor on engrafted cells is key for the development of acute graft-versus-host disease. The FDA previously granted orphan drug designation to leronlimab for the prevention of GVHD.