gallium Ga 68 gozetotide (Illuccix): FDA status

Approved Approved Jun 23, 2025. Indication: PSMA directed patient selection before taxane chemotherapy in metastatic castration resistant prostate cancer. Company: Telix Pharmaceuticals.

Regulatory history

• Jun 23, 2025: Label expanded. FDA approved label expansion of Illuccix for patient selection for PSMA targeted radioligand therapy before taxane chemotherapy in mCRPC. urologytimes.com

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