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NeoRx's picoplatin gets orphan drug designation
By Jennifer Chiou
New York, Nov. 10 - NeoRx Corp. announced it received orphan drug designation from the Office of Orphan Products Development at the U.S. Food and Drug Administration for picoplatin.
The intravenous platinum chemotherapeutic agent, which is a small cell lung cancer (SCLC) therapy, is in phase II clinical trials.
"While platinum therapies are currently used to treat SCLC, many patients do not respond or relapse within a short time after chemotherapy. As a result, there is a critical need for new therapies that are active in this disease and that can overcome the resistance that occurs with platinum compounds," chairman and chief executive officer Jerry McMahon said in a news release.
"This designation from the FDA reinforces our belief that picoplatin could be an important potential treatment option for SCLC patients."
Orphan designation, which applies to treatments for diseases that affect fewer than 200,000 people in the United States, provides an accelerated review process, tax advantages and a seven-year period of U.S. market exclusivity upon product approval, according to the release.
Seattle-based NeoRx develops and markets oncology drugs.
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