Topics:

Tykerb gains FDA approval for Rx with Femara

Tykerb gains FDA approval for Rx with Femara

The FDA granted accelerated approval for the use of lapatinib (Tykerb) with letrozole (Femara) as a first-line, oral treatment for women with metastatic disease. The combination is now indicated for postmenopausal women with HR-positive breast cancer that overexpresses the HER2 receptor. .

In the U.S. and Europe, between 60% and 70% of all breast cancers are HR-positive and between 25% and 30% overexpress HER2, according to GlaxoSmithKline, the manufacturer of Tykerb. Approval was based on results from a placebo-controlled study of 219 women. Those treated with lapatinib and letrozole experienced a 5.2-month increase in progression-free survival vs treatment with letrozole alone. Adverse reactions included diarrhea, rash, and nausea.

 
Loading comments...

By clicking Accept, you agree to become a member of the UBM Medica Community.