Kerri Fitzgerald

DocwireNews

The U.S. Food and Drug Administration&nbsp;(FDA)&nbsp;approved&nbsp;iobenguane&nbsp;I 131&nbsp;injection&nbsp;for the treatment of&nbsp;patients&nbsp;&ge;12&nbsp;years&nbsp;with pheochromocytoma or paraganglioma&mdash;rare tumors of the adrenal gland&mdash;that&nbsp;are&nbsp;unresectable, have spread beyond the original tumor site,&nbsp;and require systemic therapy. This is the&nbsp;FDA-approved therapy available for this type of tumor.&nbsp;The approval was based on&nbsp;the&nbsp;results of a single-arm, open-label trial that included&nbsp;68 patients.&nbsp;The&nbsp;study met&nbsp;its&nbsp;primary endpoint:&nbsp;17&nbsp;patients&nbsp;(25%) experienced&nbsp;a&nbsp;&ge;50%&nbsp;reduction of all antihypertensive medication for at least 6&nbsp;months, and 15 patients (22%) achieved a tumor response.&nbsp;<blockquote class="twitter-tweet" data-width="500" data-dnt="true">
FDA approves iobenguane I 131 (AZEDRA) for rare <a href="https://twitter.com/hashtag/adrenal?src=hash&amp;ref_src=twsrc%5Etfw">#adrenal</a> gland tumors <a href="https://twitter.com/hashtag/adcsm?src=hash&amp;ref_src=twsrc%5Etfw">#adcsm</a> <a href="https://t.co/h1dDmGWvln">https://t.co/h1dDmGWvln</a>
&mdash; FDA Oncology (@FDAOncology) <a href="https://twitter.com/FDAOncology/status/1024022433584570368?ref_src=twsrc%5Etfw">July 30, 2018</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>The most common severe&nbsp;adverse events were&nbsp;lymphopenia, neutropenia,&nbsp;thrombocytopenia, fatigue, anemia, increased international normalized ratio, nausea, dizziness, hypertension,&nbsp;and vomiting.&nbsp;<blockquote class="twitter-tweet" data-width="500" data-dnt="true">
FDA approves Progenics' treatment for rare adrenal gland tumors <a href="https://t.co/epzfVzVbxx">https://t.co/epzfVzVbxx</a>
&mdash; Reuters Health (@Reuters_Health) <a href="https://twitter.com/Reuters_Health/status/1024035334575845376?ref_src=twsrc%5Etfw">July 30, 2018</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>Iobenguane&nbsp;I 131&nbsp;has a risk of&nbsp;radiation exposure to patients and family members, and&nbsp;this risk&nbsp;is greater in pediatric patients. Other warnings and precautions include&nbsp;risk of&nbsp;myelosuppression, underactive thyroid, elevated&nbsp;blood pressure, renal failure or kidney injury,&nbsp;and pneumonitis.&nbsp;&nbsp;Myelodysplastic syndromes&nbsp;and acute leukemias&nbsp;were observed in patients who received&nbsp;this treatment, and&nbsp;researchers&nbsp;will continue to monitor and study this risk.&nbsp;&nbsp;<a href="https://proddocwire.wpengine.com/hematology-oncology/fda-approves-combination-therapy-for-anaplastic-thyroid-cancer/">Read more about the FDA approval of a combination therapy for anaplastic thyroid cancer.</a>&nbsp;Source:&nbsp;<a href="https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm615155.htm">Cancer&nbsp;</a>

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FDA Approves First Treatment for Rare Adrenal Gland Tumors

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The U.S. Food and Drug Administration (FDA) approved iobenguane I 131 injection for the treatment of patients ≥12 years with pheochromocytoma or ...

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