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news.The FDA has granted orphan drug designation to ZymoGenetics' compound Interleukin 21 for the treatment of melanoma patients with advanced or aggressive disease.
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The orphan drug act guarantees market exclusivity for seven years to the first sponsor that obtains market approval for an orphan-designated product.
ZymoGenetics is testing Interleukin 21 (IL-21) in an ongoing phase Ib clinical trial in melanoma and renal cell carcinoma with a dosing regimen administered in an outpatient setting.
“We’re excited about the progress of the IL-21 program,” said Dr Bruce Carter, president and CEO of ZymoGenetics. “Our studies have shown that IL-21 stimulates cells of the immune system that are thought to have a critical role in eliminating malignant cells. We believe IL-21 may come to play an important role in helping cancer patients who need an effective therapy with manageable side effects.”