The US FDA Grants Fast Track Designation to Clarity’s Cu-64 SAR-BisPSMA in Biochemical Recurrence of Prostate Cancer
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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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
