publication date: Aug. 3, 2018
Drugs & Targets FDA approves first treatment for rare adrenal tumors
FDA approved Azedra (iobenguane I 131) injection for intravenous use for the treatment of adults and adolescents age 12 and older with pheochromocytoma or paraganglioma that cannot be surgically removed, have spread beyond the original tumor site and require systemic anticancer therapy.
FDA granted the approval of Azedra to Progenics Pharmaceuticals Inc. This is the first FDA-approved drug for this use.
The efficacy of Azedra was shown in a single-arm, open-label, clinical trial in 68 patients that measured the number of patients who experienced a 50 percent or greater reduction of all antihypertensive medications lasting for at least six months.
This endpoint was supported by the secondary endpoint, overall tumor response measured by traditional imaging criteria. The study met the primary endpoint, with 17 (25 percent) of the 68 evaluable patients experiencing a 50 percent or greater reduction of all antihypertensive medication for at least six months. Overall tumor response was achieved in 15 (22 percent) of the patients studied.
As it is a radioactive therapeutic agent, Azedra includes a warning about radiation exposure to patients and family members, which should be minimized while the patient is receiving Azedra. The risk of radiation exposure is greater in pediatric patients.
FDA granted … Continue reading FDA approves first treatment for rare adrenal tumors
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