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FDA approves hormone/her2 positive drugs
Posted by: Anonymous User (IP Logged)
Date: February 09, 2010 03:28PM

THE US food and drug administration (FDA) has approved tykerb (lapatinib) in combination with femara (letrozole) to treat hormone positive and her2-positive advanced breast cancer in postmenopausal women for whom hormonal therapy is indicated.

Her2 is a protein involved in normal cell growth. It is found on some types of cancer cells, including breast cancer cells. In hormone positive breast cancer, the presence of certain hormones contributes to breast cancer growth.

In her2-positive breast cancer, stimulation of the her2 receptor contributes to cancer cell growth. Breast cancer is the second leading cause of death among women. More than 192,000 women will be diagnosed with breast cancer this year.

“This drug combination provides women being treated for advanced breast cancer with an important treatment option,” said Richard Pazdur, director of the office of oncology drug products, in the FDA’s center for drug evaluation and research.

“This entirely oral treatment regimen works by targeting both her2 and the hormone receptors, thereby slowing the cancer cells’ ability to grow or spread.”

Women with her2-positive disease receiving the tykerb plus femara combination more than doubled the time they lived without the cancer progressing compared with those receiving femara alone (35 weeks v 13 weeks).

Women in the company-sponsored study were randomized to receive Tykerb plus Femara or Femara alone. It is too early to determine whether an improvement in overall survival will be observed in the clinical trial, the FDA said.

The most commonly reported side effects of the combination were diarrhoea, rash, nausea and fatigue.

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