Tykerb Gets Priority FDA Review

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Oncology NEWS InternationalOncology NEWS International Vol 15 No 12
Volume 15
Issue 12

GlaxoSmithKline's New Drug Application for Tykerb (lapatinib), an oral small molecule dual inhibitor of EGFR and HER2, has been granted priority review by the FDA. The designation requires that the agency decide on a drug application no longer than 6 months after submission, which was September 18, 2006, for Tykerb. The Tykerb application is for treatment of advanced or metastatic HER2-positive breast cancer in combination with capecitabine (Xeloda) for patients who have received prior treatment.

LONDON, United Kingdom—GlaxoSmithKline's New Drug Application for Tykerb (lapatinib), an oral small molecule dual inhibitor of EGFR and HER2, has been granted priority review by the FDA. The designation requires that the agency decide on a drug application no longer than 6 months after submission, which was September 18, 2006, for Tykerb. The Tykerb application is for treatment of advanced or metastatic HER2-positive breast cancer in combination with capecitabine (Xeloda) for patients who have received prior treatment.

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Drug Combination Prevents ER-Negative Tumors in Mice
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Reovirus Agent Shows Activity in Phase I Trial
Eisai Acquires Four Oncology- Related Products From Ligand
Genetic Brain Tumor Study Gets $11 Million NCI Grant
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ACCC Weighs in on Critical Cancer Care Issues:
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