Posted from: Monday, September 17, 2018 - 11:55 AM - Present

Azedra Approved to Treat Rare Adrenal Tumors

July 30, 2018 – The U.S. FDA has approved Azedra® (iobenguane I 131), manufactured by Progenics, to treat pheochromocytoma or paraganglioma that has spread beyond the original tumor site and cannot be surgically removed. Eligible patients must be at least 12 years old and require systemic anticancer therapy.

Both pheochromocytoma and paraganglioma are rare tumors of the adrenal gland. Pheochromocytoma develops inside the center of the adrenal gland, while paraganglioma occurs outside of the gland. Signs and symptoms of these tumors include high blood pressure and headaches. Certain genetic factors may increase an individual’s chances of developing either type of tumor.

In some cases, the tumors are benign (noncancerous), but can still cause difficulties including high blood pressure (hypertension), weight loss, anxiety, weakness, and rapid heartrate. The prognosis for patients with cancer of these types is typically poor, with just a 12% five-year survival rate.

Standard treatment for these rare tumors includes the use of drugs to treat hypertension. In a clinical trial, 25% of patients who received Azedra were able to cut their use of hypertension medication by 50% or better for at least six months. In 22% of patients who received Azedra, their tumor size decreased.

Recommended dosing is based on weight, and Azedra should be infused in two separate doses delivered at least 90 days apart. Azedra will be available in single-dose 2mL and 30mL vials. Because it is a radiopharmaceutical, it must be administered by healthcare professionals trained to deliver these types of drugs, in facilities equipped to safely handle such treatments.

Progenics has launched Azedra at an average wholesale price (AWP) of $122,310 per dose.

Last Updated Friday, October 19, 2018 - 01:28 AM.