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The US Food and Drug Administration today approved the injection of Azedra (iobenguane I 131) for the treatment of adults and adolescents aged 12 years and older with rare tumors of the adrenal gland (pheochromocytoma or paraganglioma) that can not be removed surgically (unresectable), have spread beyond the initial tumor site and require systemic anticancer therapy. It is the first drug approved by the FDA for this use.
"Many patients with these ultra-rare cancers can be treated by surgery or by local therapies, but there is no effective systemic treatment for high blood pressure patients," said Richard Pazdur, MD, Director of the FDA Center for Excellence in Oncology and Acting Director of the Bureau of Hematology and Oncology Products at the FDA's Center for Drug Evaluation and Research. " Patients will now have an approved treatment that has been shown to decrease the need for blood pressure medications and reduce tumor size in some patients. "
Pheochromocytomas are rare tumors of the adrenal glands. just above the kidneys and produce hormones, including stress hormones called epinephrines and norepinephrines.Pheochromocytomas increase the production of these hormo nes, leading to hypertension (high blood pressure) and symptoms such as headache, irritability, sweating, rapid heartbeat, nausea, vomiting, weight loss, weakness, chest pain or anxiety. When this type of tumor occurs on the outside of the adrenal gland, it is called a paraganglioma.
The efficacy of Azedra has been demonstrated in an open, single-arm clinical trial in 68 patients measuring the number of patients having 50% or greater reduction of all antihypertensives for at least six month. This criterion was supported by the secondary endpoint, the overall tumor response measured by traditional imaging criteria. The study met the primary endpoint, with 17 (25 percent) of 68 evaluable patients having experienced a 50 percent or greater reduction in all antihypertensive medications for at least six months. Overall tumor response was achieved in 15 (22%) of the patients studied.
The most common adverse reactions reported by patients treated with Azedra in clinical trials were low white blood cell counts (lymphopenia). white blood cells (neutropenia), low platelet count (thrombocytopenia), fatigue, anemia, increased international normalized ratio (a laboratory test that measures blood clotting), nausea, dizziness, high blood pressure, and vomiting.
As it is a radioactive therapeutic agent, Azedra includes a warning regarding the radiation exposure of patients and family members, which should be minimized while the patient receives Azedra. The risk of radiation exposure is greater in pediatric patients. Other warnings and precautions include a risk of lower blood cell levels (myelosuppression), underactive thyroid, elevated blood pressure, kidney or kidney failure, and decreased blood pressure (myelosuppression), underactive thyroid, elevated blood pressure, kidney or kidney failure, and Inflammation of the lung tissue (pneumonia). Myelodysplastic syndrome and acute leukaemias, which are cancers of the blood and bone marrow, have been observed in patients who received Azedra, and the magnitude of this risk will continue to be studied. Azedra can cause damage to a developing fetus; women should be informed of the potential risk to the fetus and use effective contraception after receiving Azedra. The radiation exposure associated with Azedra can cause infertility in both males and females.
The FDA has granted the following designations: Fast Track, Breakthrough Therapy and Priority Review. Azedra has also received the orphan drug designation, which provides incentives to help and encourage the development of drugs for rare diseases.
The FDA has granted Azedra's approval to Progenics Pharmaceuticals, Inc.
of Health and Social Services, protects public health by ensuring the safety, efficacy, and safety of patients. safety of human and veterinary drugs, vaccines and other biological products for human use and medical devices. The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, products that emit electronic radiation and the regulation of tobacco products.
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