National Cancer Institute NCI Cancer Bulletin: A Trusted Source for Cancer Research News
February 9, 2010 • Volume 7 / Number 3

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FDA Update

Another Use for the Cancer Drug Lapatinib

The FDA has approved the use of the drug lapatinib (Tykerb) in combination with letrozole (Femara) to treat postmenopausal women with advanced HER2-positive and hormone receptor (HR)-positive breast cancer. While these women in the past would have received some form of hormone-deprivation therapy alone, new evidence suggests that they may benefit from the addition of lapatinib. 

The evidence comes from a phase III clinical trial, EGF30008, comparing lapatinib plus the aromatase inhibitor letrozole with letrozole alone in women with advanced, metastatic breast cancer for whom hormone deprivation therapy was indicated. Women who received the combination treatment lived more than twice as long without their cancer progressing compared with those receiving letrozole alone (35 weeks versus 13 weeks).

Patients in the combination treatment arm also had superior rates of overall disease response and stable disease, the trial’s lead investigator, Dr. Stephen Johnston of the Institute of Cancer Research in the United Kingdom, told the NCI Cancer Bulletin in 2008. “These patients would previously be treated with endocrine therapy alone,” Dr. Johnston added. “Now the suggestion is that combined therapy may be a better approach.”

It is too early to know whether an improvement in overall survival will be observed in the clinical trial, the FDA noted in a statement.

“This drug combination of Tykerb plus Femara provides women being treated for advanced breast cancer with an important treatment option,” said Dr. Richard Pazdur, director of the FDA’s Office of Oncology Drug Products, in the statement. “This entirely oral treatment regimen works by targeting both HER2 and the hormone receptors, thereby slowing the cancer cells’ ability to grow or spread.”

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