FDA Grants Fast Track Designation To Greenwich’s GLSI-100 in HER2+ Breast Cancer

Greenwich LifeSciences, Inc., a clinical-stage biopharmaceutical company advancing immunotherapies to prevent breast cancer recurrences, announced that the U.S. FDA has granted Fast Track designation to GLSI-100 for patients with the HLA-A*02 genotype and HER2-positive breast cancer who have completed standard HER2/neu-targeted therapy.

Dr. Jaye Thompson, VP Clinical and Regulatory Affairs, said, "Greenwich is pleased that the FDA sees the potential of GLSI-100 to change important clinical outcomes in this population of breast cancer patients. We continue to work earnestly to collect data to support a BLA filing demonstrating this benefit."

The designation underscores GLSI-100’s potential to improve invasive breast cancer–free survival in this patient population and provides an opportunity for more frequent FDA interactions to help expedite clinical development and regulatory review.

CEO Snehal Patel said, "We are excited to have received Fast Track designation. The FDA review of our Fast Track application included a review of the potential of GLSI-100 as a new drug to treat serious conditions and to fill unmet medical needs. By showing the potential of GLSI-100 to prevent metastatic breast cancer recurrence in the patient population that we are studying, we were able to estimate the potential lives that could be saved. The Company plans to continue discussions with the FDA, and potentially the European regulatory authorities, to explore additional ways to make GP2 and GLSI-100 available to larger populations."

With Fast Track status, Greenwich may benefit from regulatory mechanisms such as rolling Biologic License Application (BLA) submissions, allowing portions of the BLA from the ongoing Phase III FLAMINGO-01 trial to be submitted and reviewed as they are completed. This could potentially accelerate the timeline for GLSI-100’s approval and availability to patients.