FDA Oncology Announcements

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5 Announcements

FDA expands Pluvicto’s metastatic castration-resistant prostate cancer indication

Trial: PSMAfore
Drug: Pluvicto (lutetium Lu 177 vipivotide tetraxetan) · Radioactive agent
Condition: Genitourinary

FDA approves lutetium Lu 177 dotatate for pediatric patients 12 years and older with GEP-NETS

Trials: NETTER-P, NETTER-1
Drug: Lutathera (lutetium Lu 177 dotatate) · Radioactive agent
Condition: Endocrine

FDA approves Pluvicto for metastatic castration-resistant prostate cancer

Trial: VISION
Drug: Pluvicto (lutetium Lu 177 vipivotide tetraxetan) · Radioactive agent
Condition: Genitourinary

FDA approves iobenguane I 131 for rare adrenal gland tumors

Drug: AZEDRA (iobenguane I 131) · Radioactive agent
Condition: Endocrine

FDA approves lutetium Lu 177 dotatate for treatment of GEP-NETS

Trial: NETTER-1
Drug: LUTATHERA (lutetium Lu 177 dotatate) · Radioactive agent
Condition: Endocrine