|Articles|December 1, 2006

Oncology NEWS International

Oncology NEWS International Vol 15 No 12
Volume 15
Issue 12

Tykerb Gets Priority FDA Review

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 KingdomGlaxoSmithKline'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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Tykerb Gets Priority FDA Review

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