Research & Development
Full-Life Technologies' 225Ac-FL-020 receives US FDA Fast Track Designation to treat metastatic castration-resistant prostate cancer
3 July 2024 -

Full-Life Technologies, a China-based, fully integrated global radiotherapeutics company, announced on Tuesday that it has received Fast Track Designation from the US Food and Drug Administration (FDA) for 225Ac-FL-020, the company's lead radiopharmaceutical that targets prostate-specific membrane antigen (PSMA) and is intended for the treatment of metastatic castration-resistant prostate cancer (mCRPC).

The Fast Track program is designed to facilitate the development and regulatory review of novel potential therapies intended to treat serious conditions and fill an unmet need. This designation is claimed to highlights the potential of 225Ac-FL-020 to provide a novel therapeutic option for patients with mCRPC, a condition for which there are currently limited effective treatments.

Steffen Heeger, MD, MSc., Full-Life chief medical officer, said: "The FDA Fast Track Designation for 225Ac-FL-020 underscores the critical need for innovative and effective treatments for mCRPC. This designation will enable us to collaborate more closely with the FDA throughout the development process, potentially accelerating the availability of 225Ac-FL-020 to patients."