FDA Approved Iobenguane I-131 for Rare Neuroendocrine Tumors
Trade name Azedra.
Lobenguane I-131 (Azedra) approved for adult and pediatric patients aged ≥12 years with iobenguane scan–positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy.
The radiopharmaceutical drug therapy elicited a ≥50% reduction in antihypertensive medication use for ≥6 months, which was the primary endpoint of the trial, for 25% of patients with pheochromoma or paraganglioma.
It has been shown to decrease the need for blood pressure medication and reduce tumor size in some patients.
Patients with MIBG-avid pheochromocytoma or paraganglioma who were ineligible for curative surgery, failed prior therapy, or were not candidates for chemotherapy- Iobenguane I-131 was given at an initial dosimetric dose of 111 to 222 MBq at the time of enrollment, which was followed by a therapeutic dose of 296 MBq/kg.
The ORR, which consisted entirely of partial responses, was 23.4% with iobenguane I-131 for all patients in the trial.
31.4% of patients had a ≥50% reduction in antihypertensive medication use, and the median duration of clinical benefit was 13.3 months.
The most common adverse events which occurred in ≥50% of patients, included nausea, myelosuppression, and fatigue.