Positive guidance from US FDA on Cu-64 SAR-bisPSMA Phase III trial in prostate cancer

Written by PR Newswire

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,...

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