GSK's Breast Cancer Drug Gets 'Priority Review'
Posted November 17, 2006
RESEARCH TRIANGLE PARK, N.C. — GlaxoSmithKlines
breast cancer drug Tykerb will receive a priority review from the Food and Drug Administration, several news services reported Friday.
The news means Tykerb could win approval within six months. GSK is proposing that Tykerb be used in conjunction with the chemotherapy drug Xeoloda to treat advanced breast cancer.
The drug was also granted a priority review in Australia earlier this month.
One analyst cited by Dow Jones News Service described the FDA move as a strong endorsement of Tykerb as being a pivotal cancer treatment and forecast sales of $2 billion a year.
GSK maintains one of its two U.S. headquarters in Research Triangle Park and employs some 6,000 people in the Triangle region.