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LCA News:
LCA Issues Statement on FDA Priority Review for Small Cell Lung Cancer Treatment--Oral Hycamtin®
Washington DC [June 14, 2007]--Lung Cancer Alliance applauds the Food and Drug Administration’s (FDA) recent decision to grant Priority Review for Oral Hycamtin, a treatment for relapsed small cell lung cancer manufactured by GlaxoSmithKline. Priority review allows for expedited review of clinical trial data, potentially minimizing the time between trial completion and FDA approval.
The FDA granted this review on the basis of encouraging results from a recently concluded Phase III trial comparing Oral Hycamtin plus best supportive care to best supportive care alone. In this study, median survival doubled in those patients treated with the drug.
Since lung cancer patients, specifically those with small cell lung cancer, have so few treatment options available, the priority review of this clinical trial will provide answers and hopefully a new treatment option sooner.
We are grateful for GlaxoSmithKline’s commitment to developing options to meet the needs of the lung cancer community--patients and doctors alike.
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