CU6: Positive Guidance from FDA on Phase 3 Prostate Cancer Trial
CLARITY PHARMACEUTICALS LTD
- The US Food and Drug Administration (FDA) has given a positive nod for a pivotal Phase III trial for 64Cu SAR-bisPSMA diagnostic in prostate cancer, with 383 patients to participate in a single-arm, open-label, multi-center trial projected to start in late 2023.
- Upon successful completion, results from the trial will assist in submitting an application to the FDA for approval of 64Cu SAR-bisPSMA as a new diagnostic imaging agent for prostate cancer.
- Dr. Alan Taylor, Executive Chairperson at Clarity, expressed the company's eagerness to advance to Phase III clinical trials, highlighting that the endeavor is backed by convincing preclinical and clinical data, scientific collaborators, participating patients and Clarity's devoted team.
2023-07-04 08:20:00