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UK MHRA Approves Trofolastat for Prostate Cancer Imaging
The UK MHRA has approved Trofolastat (RoTecPSMA), a PSMA-targeting agent used with Technetium-99m for detecting prostate cancer lesions. The radioactive isotope enables SPECT imaging, helping doctors assess cancer spread, recurrence, and treatment eligibility for metastatic cases.
Trofolastat, originally developed by Progenics Pharmaceuticals, showed 94.2% sensitivity in a 105-patient clinical study. As the first PSMA-targeting agent approved with Technetium-99m, which is widely available in UK nuclear medicine facilities, the approval is expected to enhance NHS diagnostic access.
Prostate cancer is one of the most common cancers in UK men, with 55,000 new cases annually. This approval aligns with the MHRA’s broader efforts to improve medical safety communication, including new monthly safety bulletins for healthcare professionals.
02-04-2025