I know some of you don’t like AI answers but her
Post# of 155056
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Posted On: 04/04/2025 9:00:41 PM
I know some of you don’t like AI answers but here is what ChatGPT says. Not sure how reliable this answer is:
Is FDA Fast Track designation still in place for Leronlimab or has it expired or been revoked?
As of April 2025, there is no publicly available information indicating that the FDA’s Fast Track designations for leronlimab have been revoked or have expired. Leronlimab received Fast Track designation from the FDA in May 2019 for two indications:  
1. Combination Therapy with HAART for HIV-Infected Patients: This designation aimed to expedite the development of leronlimab as part of a combination treatment for HIV.
2. Treatment of CCR5-Positive Metastatic Triple-Negative Breast Cancer (mTNBC): Leronlimab was granted Fast Track status for use in combination with carboplatin for patients with this specific type of breast cancer. 
While CytoDyn, the developer of leronlimab, voluntarily withdrew its Biologics License Application (BLA) for leronlimab as a combination therapy for HIV in October 2022 due to data collection and monitoring issues, there have been no reports indicating that the Fast Track designations themselves have been revoked or have expired. 
Furthermore, in March 2025, the FDA cleared the initiation of a Phase 2 study evaluating leronlimab for the treatment of patients with microsatellite-stable relapsed/refractory metastatic colorectal cancer, suggesting ongoing regulatory engagement with the drug’s development. 
Therefore, based on the available information, the Fast Track designations for leronlimab remain in place.
Is FDA Fast Track designation still in place for Leronlimab or has it expired or been revoked?
As of April 2025, there is no publicly available information indicating that the FDA’s Fast Track designations for leronlimab have been revoked or have expired. Leronlimab received Fast Track designation from the FDA in May 2019 for two indications:  
1. Combination Therapy with HAART for HIV-Infected Patients: This designation aimed to expedite the development of leronlimab as part of a combination treatment for HIV.
2. Treatment of CCR5-Positive Metastatic Triple-Negative Breast Cancer (mTNBC): Leronlimab was granted Fast Track status for use in combination with carboplatin for patients with this specific type of breast cancer. 
While CytoDyn, the developer of leronlimab, voluntarily withdrew its Biologics License Application (BLA) for leronlimab as a combination therapy for HIV in October 2022 due to data collection and monitoring issues, there have been no reports indicating that the Fast Track designations themselves have been revoked or have expired. 
Furthermore, in March 2025, the FDA cleared the initiation of a Phase 2 study evaluating leronlimab for the treatment of patients with microsatellite-stable relapsed/refractory metastatic colorectal cancer, suggesting ongoing regulatory engagement with the drug’s development. 
Therefore, based on the available information, the Fast Track designations for leronlimab remain in place.
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