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Elvina Almuradova: The FDA has granted fast track designation to 67Cu-SAR-bisPSMA for PSMA-positive mCRPC
Feb 28, 2025, 14:50

Elvina Almuradova: The FDA has granted fast track designation to 67Cu-SAR-bisPSMA for PSMA-positive mCRPC

Elvina Almuradova, Associate Professor of Oncology at the European Institute of Oncology (IEO), shared a post on LinkedIn:

“The FDA has granted fast track designation to 67Cu-SAR-bisPSMA for PSMA-positive mCRPC after ARPI, based on promising phase 1/2a SECuRE trial data.

  • No dose-limiting toxicities in 15 patients.
  • 73% had PSA reductions, with 45% showing >50% decline after a single dose.
  • Mild side effects, most commonly dry mouth (33%).

This could be a game-changer in PSMA-targeted radiotherapy, offering an alternative to 177Lu-based treatments.

Looking forward to further developments!”