Clarity Pharmaceuticals receives third FDA review for prostate cancer diagnostic
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The news: Sydney-based Clarity Pharmaceuticals has received a third fast track designation (FTD) from the US Food and Drug Administration (FDA) for its imaging agent Cu-SAR-bisPSMA, a novel diagnostic option for patients with prostate cancer.
The context: The FDA has granted the FTD for Cu-SAR-bisPSMA for adult patients with PSMA-positive metastatic castration-resistant prostate cancer, who have been previously treated with androgen receptor pathway inhibition (ARPI).
Clarity received its first FTD for the diagnostic last year, for patients with suspected metastasis of prostate cancer who are candidates for initial definitive therapy.
Last month, the FDA granted Clarity a second FTD for Cu-SAR-bisPSMA for patients with biochemical recurrence of prostate cancer following definitive therapy.
Clarity said the three FTDs demonstrate the "quality of the data generated to date" on the Cu-SAR-bisPSMA products in addressing serious unmet needs in prostate cancer.
The FTDs will enable Clarity to accelerate the development of its program with the optimised SAR-bisPSMA agent to be used in patients with prostate cancer through the management of their cancer, with initial to late-stage disease, the company noted.
It poses an "opportunity to completely change the entire treatment landscape for the large prostate cancer market", Clarity said.
The FDA's FTD is designed to expedite the development and regulatory review of novel drugs addressing serious conditions with significant unmet medical needs.
The source: ASX announcement
