FDA has granted Fast Track Designation (FTD) to Full-Life Technologies’ (Full-Life) investigational radiopharmaceutical, 225Ac-FL-020, for the treatment of metastatic castration-resistant prostate cancer (mCRPC) targeting prostate-specific membrane antigen (PSMA).
In May 2024, Full-Life obtained FDA clearance for their Investigational New Drug (IND) Application, which included a phase I clinical trial for 225Ac-FL-020 in patients with mCRPC.
Steffen Heeger, M.D., CMO of Full-Life, emphasized the FDA’s recognition of a significant milestone with the FTD for 225Ac-FL-020.
This designation underscored the critical need for innovative and effective treatments for mCRPC, potentially accelerating the availability of 225Ac-FL-020 to patients by enabling closer collaboration with the FDA throughout the development process.
The FDA acknowledged the development of 225Ac-FL-020 for patients with mCRPC.
The FTD offered 225AC-FL-020 potential for an expedited review, ultimately providing mCRPC patients quicker access to potentially life-saving treatments.
Source: Full-Life Technologies Granted FDA Fast Track Designation for 225Ac-FL-020 for the Treatment of Metastatic Castration-Resistant Prostate Cancer
https://www.prnewswire.com/news-releases/full-life-technologies-granted-fda-fast-track-designation-for-225ac-fl-020-for-the-treatment-of-metastatic-castration-resistant-prostate-cancer-302186673.html
