
GlaxoSmithKline announced that the FDA approved its drug Tykerb
(lapatinib) in combination with Novartis’ Femara (letrozole) as a first-line treatment for patients with metastatic breast cancer.
The accelerated approval means Tykerb can be used in combination
with Femara to treat "hormone positive and HER2-positive advanced
breast cancer in postmenopausal women for whom hormonal therapy is indicated," the FDA stated. The
agency added that study results demonstrated that patients who received the drug combination lived more
than twice as long without their cancer progressing compared with those who received Femara alone.
Tykerb received US approval in 2007 for use in combination with Roche’s Xeloda (capecitabine) as a treatment
for advanced or metastatic HER2-positive breast cancer.
