medwireNews: The radiopharmaceutical iobenguane I-131 has received a positive decision by the US FDA and can now be prescribed for the treatment of inoperable advanced pheochromocytoma or paraganglioma.
The agent is approved for adults and pediatric patients aged at least 12 years who need systemic therapy for iobenguane scan-positive, locally advanced or metastatic disease. It should be given as an initial dosimetric dose, followed by two therapeutic doses that are adjusted by dosimetry, according to the FDA decision. The recommended therapeutic dose varies by bodyweight, at 296 MBq/kg (8 mCi/kg) for individuals weighing no more than 62.5 kg and 18,500 MBq (500 mCi) for heavier patients.
In the phase II MIP-IB12B trial on which this approval is based, a quarter of 68 patients were able to at least halve their use of all antihypertensive medications for 6 months or more, while around a fifth (22%) achieved an overall response as per RECIST criteria; more than half (53%) of responses lasted for at least 6 months.
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