GSK Gets Expanded Indication for Cancer Drug

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By: Tim Wright

Editor-in-Chief, Contract Pharma

GlaxoSmithKline received approval from the FDA for Hycamtin in combination with cisplatin for the treatment of stage IV-B, recurrent, or persistent carcinoma of the cervix, which is not amenable to curative treatment with surgery and/or radiation therapy. Following a six-month priority review by the FDA, the expanded indication is based on Phase III results that demonstrated a survival advantage by using Hycamtin in combination with cisplatin compared to cisplatin alone. The randomized, mul...

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