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FDA approves Progenics’ Azedra

The Food and Drug Administration has approved Progenics Pharmaceuticals’ Azedra (iobenguane I 131) injection for intravenous use, the company announced Tuesday. The drug is indicated for the treatment of adults and adolescents age 12 years old and older with rare tumors of the adrenal gland — pheochromocytoma or paraganglioma — that cannot be surgically removed — unresectable — have spread beyond the original tumor site and require systemic anticancer therapy. This is the first FDA-approved drug for this use, Progenics said.

"Many patients with these ultra-rare cancers can be treated with surgery or local therapies, but there are no effective systemic treatments for patients who experience tumor-related symptoms, such as high blood pressure," said Richard Pazdur, FDA's oncology center of excellence director and acting director of the office of hematology and oncology products in the FDA's center for drug evaluation and research.

"Patients will now have an approved therapy that has been shown to decrease the need for blood pressure medication and reduce tumor size in some patients."

Pheochromocytomas are rare tumors of the adrenal glands, which produce such hormones as epinephrine and norepinephrine. Pheochromocytomas increase the production of these hormones, leading to hypertension andsuch symptoms as headaches, irritability, sweating, rapid heart rate, nausea, vomiting, weight loss, weakness, chest pain or anxiety. When this type of tumor occurs outside the adrenal gland, it is called a paraganglioma.
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