FDA Grants Fast-Track Designation for mCRPC Theranostics
Full-Life Technologies announced that the US FDA has granted Fast Track Designation for 225Ac-FL-020, the company's lead radiopharmaceutical, which targets prostate-specific membrane antigen (PSMA), 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 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.
"The FDA Fast Track Designation for 225Ac-FL-020 underscores the critical need for innovative and effective treatments for mCRPC", said Steffen Heeger, MD, MSc, Chief Medical Officer of Full-Life. "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."
225Ac-FL-020 employs targeted alpha-radiotherapy designed to selectively attack cancer cells, reducing the damage to healthy tissues. In preclinical models, radiolabeled FL-020 displayed a very promising in vivo biodistribution profile, with high and sustained tumor uptake and fast systemic clearance. 225Ac-FL-020 exhibited robust anti-tumor activity in LNCaP xenograft mice, with a favorable safety profile. The Phase I clinical trial will evaluate the safety, tolerability, and anti-tumor activity of 225Ac-FL-020. In May 2024, Full-Life received clearance of its Investigational New Drug (IND) Application from the FDA for clinical trials of 225Ac-FL-020.