Onco-Summaries: Daily Oncology Updates at a Glance

10/09/2025

Greenwich LifeSciences' GLSI-100 received the FDA fast track designation for HER2+ve breast cancer (Ref)

The US FDA granted the Fast Track Designation to Greenwich LifeSciences' GLSI-100 (GP2 + GM-CSF) for the treatment of patients with HLA-A*02 genotype and HER2+ve breast cancer who have completed treatment with standard of care HER2/neu targeted therapy.

• Dr. Jaye Thompson, VP Clinical and Regulatory Affairs, Greenwich: "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, Greenwich: "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."

Corcept Therapeutics' NDA for relacorilant has been accepted by the US FDA for platinum-resistant ovarian cancer (Ref)

The US FDA accepted Corcept Therapeutics' NDA for relacorilant (selective glucocorticoid receptor antagonist) as a treatment for patients with platinum-resistant ovarian cancer.

• A PDUFA date of July 11, 2026 has been assigned for the application

  
  

• The NDA is based on positive data from the pivotal Phase 3 ROSELLA and Phase 2 trials

  
  

• Joseph Belanoff, M.D., CEO, Corcept: “The FDA's acceptance of our NDA brings us closer to offering a much-needed treatment option to patients with this dire disease. Relacorilant has the potential to redefine how platinum-resistant ovarian cancer is treated.”