After a unanimous recommendation from its advisory panel in December, FDA Approves Femara as Initial Treatment for Advanced Breast Cancer (dateline January 12, 2001) | Breast Health News | Imaginis - The Women's Health & Wellness Resource Network

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FDA Approves Femara as Initial Treatment for Advanced Breast Cancer (dateline January 12, 2001)

After a unanimous recommendation from its advisory panel in December, the U.S. Food and Drug Administration (FDA) approved the drug Femara (generic name, letrozole) as an initial treatment option ("first-line therapy") for women with advanced breast cancer. The FDA’s decision was based on data that showed Femara may be more effective than tamoxifen, the standard drug used to treat advanced breast cancer.

In a study of more than 900 post-menopausal women, researchers found that Femara helped delay the progression of advanced (metastatic) breast cancer longer than tamoxifen (brand name, Nolvadex). It took an average of 9.4 months for cancer to progress with Femara versus six months with tamoxifen. Researchers also found that tumor response rate and overall clinical benefit was better with Femara than tamoxifen.

Another study of 324 post-menopausal women with large or locally advanced breast cancer tumors also showed that Femara was more beneficial than tamoxifen in helping to shrink tumor size before breast-conserving surgery (lumpectomy).  FDA drug chief Robert Temple, MD called Femara impressive.

"FDA approval of this new indication means that thousands of post-menopausal women with advanced breast cancer will have a more effective hormonal treatment option," said David Parkinson, MD, Vice President of Clinical Research at Novartis Oncology in a Norvartis media release. Femara is also approved to help treat women who do not respond well to tamoxifen or become resistant to it.

Femara belongs to a class of drugs called aromatase inhibitors and works differently than tamoxifen. To grow and reproduce, breast cancer cells require the female hormone estrogen. Tamoxifen is an anti-estrogen and works by blocking estrogen from breast cancer cells, thereby "starving" cancer cells. In contrast, Femara works by reducing the total amount of estrogen in the body (circulating estrogen levels), thereby limiting the amount of estrogen that can affect breast cancer cells. Other examples of aromatase inhibitors include Arimidex (generic name, anastrozole) and Aromasin (generic name, exemestane). Both of these drugs are also used to help treat advanced breast cancer in women whose breast cancer tumors have not responded well to tamoxifen.

In the study of 900 women, side effects from Femara and tamoxifen were similar. The most frequently reported side effects of Femara include:

  • Bone pain
  • Hot flashes
  • Back Pain
  • Nausea
  • Arthralgia (joint pain)
  • Dyspnea (labored breathing)

It is estimated that approximately one half of all newly detected breast cancers have already progressed to advanced stages. Monthly breast self-exams, physician-performed clinical breast exams and annual screening mammograms (beginning at age 40) can help detect breast cancer in its earliest stages, when the chances of successful treatment and survival are greatest. Advances in treatment are also giving women with advanced breast cancer more options and helping to extend their survival time.

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