Blog

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

Elvina Almuradova/LinkedIn

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!”

67Cu-SAR-bisPSMA cancer Elvina Almuradova European Institute of Oncology FDA fight against cancer Global fight against cancer IEO mCRPC OncoDaily Oncology PSA radiotherapy

Dr. Manette Le Grange joins OncoDaily Editorial Board

FDA Grants Priority Review to Merck’s Application for KEYTRUDA® (pembrolizumab) Plus Standard of Care as Perioperative Treatment for Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma

New Paper Alert Real-Life Impact of Enfortumab Vedotin or Chemotherapy in the Sequential Treatment of Advanced Urothelial Carcinoma: The ARON-2 Retrospective Experience

Highlights from TTLC2025

KIMMTRAK (Tebentafusp) uses in Cancer: Dosages, Indications, Expectations and more