FDA grants Fast Track designation for Greenwich LifeSciences' GLSI-100.

Greenwich LifeSciences, a clinical-stage biopharmaceutical company, announced that FDA has granted Fast Track designation for GLSI-100, an immunotherapy to prevent breast cancer recurrences, in the HLA-A*02 patient population. The designation may lead to earlier drug approval and more frequent communication with the FDA to expedite the Biologic License Application filing.

Greenwich LifeSciences, Inc. (Nasdaq: GLSI), a clinical-stage biopharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences, specifically for the HLA-A*02 patient population Greenwich LifeSciences' GLSI-100 Granted US FDA Fast ...^[1]. The designation is significant as it may expedite the drug approval process and facilitate more frequent communication between the company and the FDA.

GLSI-100 is being evaluated in the Phase III clinical trial FLAMINGO-01, which is designed to assess the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who have completed neoadjuvant and postoperative adjuvant trastuzumab-based treatment. The trial involves approximately 500 HLA-A*02 patients randomized to GLSI-100 or placebo, with an additional arm for patients of other HLA types .

The Fast Track designation recognizes the potential of GLSI-100 to address an unmet medical need by preventing metastatic breast cancer recurrence in the HLA-A*02 patient population. According to Dr. Jaye Thompson, VP Clinical and Regulatory Affairs at Greenwich LifeSciences, the designation reflects the company's commitment to collecting data to support a Biologic License Application (BLA) filing demonstrating the drug's clinical benefits Greenwich LifeSciences' GLSI-100 Granted US FDA Fast ...^[1].

CEO Snehal Patel expressed excitement about the Fast Track designation, noting that it highlights the potential of GLSI-100 to save lives by preventing breast cancer recurrences. The company plans to continue discussions with the FDA and potentially European regulatory authorities to explore additional ways to make the drug available to larger populations Greenwich LifeSciences' GLSI-100 Granted US FDA Fast ...^[1].

The Fast Track process allows for more frequent communication between the FDA and drug developers, enabling quicker resolution of questions and issues, which can lead to earlier drug approval and patient access. Greenwich LifeSciences may also utilize a rolling review process, where completed sections of the BLA can be submitted for review while other parts of the application are still being completed Greenwich LifeSciences' GLSI-100 Granted US FDA Fast ...^[1].

The Phase IIb clinical trial results for GLSI-100 showed an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients treated with the immunotherapy, compared to a 20-50% reduction by other approved products. The drug demonstrated a potent immune response and was well-tolerated, with no reported serious adverse events related to treatment .

With the Fast Track designation, Greenwich LifeSciences is poised to accelerate the development and approval process for GLSI-100, potentially bringing a new treatment option to patients with breast cancer who have completed standard of care HER2/neu targeted therapy.