Shots:
- FDA has granted FTD to Cu-64 SAR-bisPSMA for PET scans of PSMA+ lesions in pts with BCR post-receiving SoC, based on a P-I/II (COBRA) trial assessing it (same & next day) in patients who had an SoC scan at study entry
- Study showed that it localized disease in ~80% patients & detected double the lesions as small as 2mm the next day. Submission also featured its bivalent bisPSMA structure & longer t½ (12.7 hrs vs <2 hrs for F-18/Ga-68) enabling earlier detection
- Also, it will enter Co-PSMA IIT assessing its performance vs Ga-68 PSMA-11 & P-III (AMPLIFY) trial in ~220 pts with rising or detectable PSA post-receiving SoC. P-III data will back the application for FDA approval
Ref: Prnewswire | Image: Clarity
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