Clarity Pharmaceuticals has secured fast-track designation from the U.S. Food and Drug Administration (FDA) for its copper-67 (Cu-67) SAR-bisPSMA radiopharmaceutical for treating advanced prostate cancer.
The classification builds on Clarity’s earlier receipt of fast-track designation for its PET diagnostic imaging agent Cu-64 SAR-bisPSMA for identifying patients with the disease. The radiopharmaceutical and imaging agent are a theranostics pair in development for use in patients from initial to late-stage disease, the company noted.
The FDA’s fast-track designation is designed to expedite the development and regulatory review of novel drugs addressing serious conditions with significant unmet medical needs. A safety review committee meeting on Cu-67 SAR-bisPSMA is planned for March 2025, Clarity noted.