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 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.
Newsletter
Stay up to date on recent advances in the multidisciplinary approach to cancer.
![“These results and the lack of systemic toxicity observed with [TTFields] provide patients with a promising new treatment option,” according to Joachim Aerts, MD, an investigator of the phase 3 LUNAR trial (NCT02973789).](/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fcancernetwork%2F7d7dfad7849391f4be3ebd2cf39c24f5369cfcd1-1200x1176.jpg%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=75 "“These results and the lack of systemic toxicity observed with [TTFields] provide patients with a promising new treatment option,” according to Joachim Aerts, MD, an investigator of the phase 3 LUNAR trial (NCT02973789).")
