IsoRay Announces FDA Clearance Supporting Enhanced Loading And Delivery Methods For The Treatment Of Lung, Head And Neck, And Other Tumors

Main Category: Cancer / Oncology
Also Included In: Regulatory Affairs / Drug Approvals;  Lung Cancer
Article Date: 20 Aug 2009 - 1:00 PDT

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IsoRay, Inc. (Amex:ISR) announced that it has received clearance from the FDA for its Premarket Notification, [510(k)] for Proxcelan™ Cesium-131 Brachytherapy Seeds enabling the company to preload Cesium-131 into flexible braided strands and surgical mesh. This FDA clearance allows IsoRay to market Cesium-131 seeds for use in the treatment of cancers well beyond the current prostate market.

This order clears the product for commercial distribution for treatment of lung and head and neck tumors as well as tumors in other organs. While Cesium-131 seeds themselves have been cleared for this indication since 2003, this current 510(k) allows Cesium-131 to be delivered in a new, convenient and sterile format that can be implanted without additional seed loading by the facility. The 510(k) also clears the application of the braided strands onto a bioabsorbable mesh matrix to further facilitate implant procedures.

Dwight Babcock, IsoRay CEO, stated. "The FDA's decision will accelerate our strategy to significantly broaden the scope of Cesium-131 cancer treatments well beyond the current major prostate market. A growing number of physicians have indicated that they believe Cs-131's unique characteristics of shorter half life and high energy are particularly suitable for many applications beyond prostate."

In 2008 it was estimated that there were a total of 47,560 head and neck cases and 220,000 cases of lung cancer diagnosed in the United States. (Cancer Management: A Multidisciplinary Approach, 11th Edition (2008). Richard Pazdur, Lawrence R. Coia, William J. Hoskins, Lawrence D. Wagman; American Cancer Society, 2009.)

Source
IsoRay

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