Clinical-stage radiopharmaceutical company Clarity Pharmaceuticals (ASX:CU6) has announced that the US FDA has granted fast-track designation for 67Cu-SAR-bisPSMA for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been previously treated with androgen receptor pathway inhibition (ARPI).
The company said it has previously received two fast-track designations for the diagnostic 64Cu-SAR-bisPSMA in patients with suspected metastasis of prostate cancer who are candidates for initial definitive therapy, as well as patients with biochemical recurrence of prostate cancer following definitive treatment, with 2 Phase 3 registration trials underway.
The designations are designed to expedite the development and regulatory review of novel drugs addressing serious conditions with significant unmet medical needs.
Clarity’s executive chairperson Dr Alan Taylor said, “Receiving 3 FTDs [fast-track designations] for the one molecule, SAR-bisPSMA, within the last 6 months is an incredible achievement for Clarity, highlighting how impressive our science and development are, the significance of the diagnostic and therapeutic data so far, and the high unmet need for better therapies and diagnostics in prostate cancer.
“The dual-targeted bisPSMA molecule was developed at the benchtop of Australian science with the intent of overcoming the shortfalls of the current generation of PSMA-targeting products. It was optimised with two PSMA ligands, which increases not only the amount of product in the lesions, but also how long the product is retained in the lesions over time, making it an ideal candidate for both diagnosis and therapy. The clinical data in both diagnostic and therapeutic indications that we are generating is remarkable, confirming the results that we initially saw in preclinical development."
Dr Taylor added, “These designations will allow us to work closely with the FDA to facilitate the development process and accelerate the approval of what could become best-in-class therapy and diagnostic agents, and our team and collaborators are committed to making this our priority in order to achieve our ultimate goal of improving treatment outcomes for people with cancer."