Greenwich LifeSciences (NASDAQ: GLSI) announced that the FDA has granted GLSI-100 fast track designation for the treatment of patients with HLA-A*02 genotype and HER2-positive breast cancer who have completed treatment with standard of care HER2/neu targeted therapy.
According to Greenwich, this designation may lead to earlier drug approval as the company and the FDA can communicate more frequently to expedite the Biologic License Application (BLA) filing of the clinical and manufacturing data from the Phase 3 clinical trial, FLAMINGO-01, to evaluate the safety and efficacy of GLSI-100.
In a statement, Dr. Jaye Thompson, VP Clinical and Regulatory Affairs of Greenwich, commented, “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.”
Snehal Patel, CEO of Greewich added, “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 need. 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.”
