Small Cell Lung Cancer

FDA Grants Priority Review for Oral Formulation of HYCAMTIN (topotecan) to Treat Relapsed Small Cell Lung Cancer

Published in Law and Health Weekly, June 30th, 2007

GlaxoSmithKline (GSK) announced that its new drug application (NDA) for ORAL HYCAMTIN(R) (topotecan) capsules, a treatment for relapsed small cell lung cancer (SCLC), has been granted Priority Review by the United States Food and Drug Administration (FDA).

This application was based on encouraging results from a Phase III study comparing ORAL HYCAMTIN plus best supportive care (BSC) to BSC alone in patients with relapsed SCLC, in addition to two Phase II and Phase III supporting studies. The data from the pivotal Phase III trial were published in the December 1, 2006 issue of the Journal of Clinical Oncology.(1) BSC refers to treatments intended to control, prevent and...

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Source: Law and Health Weekly (2007-06-30)

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