Positive guidance from US FDA on Cu-64 SAR-bisPSMA Phase III trial in prostate cancer
Sydney, Australia 4 July 2023 Highlights FDA agreement for a pivotal Phase III trial for 64Cu SAR-bisPSMA diagnostic in prostate cancer Phase III trial design based on 64Cu SAR-bisPSMA data package, including positive results from the completed PROPELLER trial A total of 383 prostate cancer patients to take part in a pivotal, non-randomised, single-arm, open-label,…