Genentech has been denied accelerated approval for its investigational breast cancer treatment trastuzumab-DM1 (T-DM1), a move likely to push the drug’s potential market entry back at least two years. The FDA issued a refuse-to-file letter for the BLA for T-DM1, a combination of Genentech’s Herceptin (trastuzumab) and ImmunoGen’s cancer-killing agent DM1, because all available treatment options for metastatic breast cancer were not exhausted

I’m looking down a powerful microscope at breast cancer cells, a little cluster of them multiplying all by themselves in a nutritious pink culturing fluid. You can barely see them unless you’re told what to look for — they’re insignificant, irregular, too chaotic to make a person die. But they do:

Susan G. Komen for the Cure® and the Ovarian Cancer National Alliance (OCNA) today urged the U.S. Food and Drug Administration (FDA) to continue to allow the use of the drug bevacizumab, commonly known as Avastin, for metastatic breast cancer patients, noting that it is effective for some patients and warning of a chilling effect on new drug development if approval is withdrawn.

In a prospective study of 251 women with HER2-positive breast cancer, women with elevated blood levels of a protein called troponin I had significantly higher rates of cardiotoxicity (heart damage) during treatment with trastuzumab (Herceptin) than women who did not have elevated levels of troponin I before or during treatment.

On July 20, the Oncologic Drugs Advisory Committee (ODAC) of the FDA’s Center for Drug Evaluation and Research voted 12 to 1 to recommend against the use of bevacizumab (Avastin) in combination with chemotherapy for the first-line treatment of metastatic breast cancer

By Emily P. Walker, Washington Correspondent, MedPage Today
Published: July 20, 2010

GAITHERSBURG, Md. — An advisory panel has voted 12 to 1 to recommend that the FDA remove the advanced breast cancer indication from bevacizumab (Avastin), after two large clinical trials failed to demonstrate a clinically meaningful benefit of the drug, which carries serious side effects.

WASHINGTON — Adding bevacizumab (Avastin) to chemotherapy drugs doesn’t increase survival or improve symptoms for women with advanced breast cancer, according to FDA documents posted in advance of an advisory panel meeting on Tuesday.

Danny Welch, Ph.D., is a senior scientist in the UAB Comprehensive Cancer Center and a renowned expert in the biology and genetics of cancer metastasis - the process by which cancer cells break away from a primary tumor and enter the bloodstream or lymphatic system and spread to other parts of the body.

On average, about five percent of total cancer research funding is spent on investigating metastases (the spread of cancer cells around the body) in Europe, yet metastatic disease is the direct or indirect cause of 90 percent of all cancer deaths, according to an editorial in the European Journal of Cancer (EJC). [1]

9th July 2010 — In draft guidance issued today by the National Institute for Health and Clinical Excellence (NICE), the drug bevacizumab (Avastin) is not recommended for use in combination with a taxane for patients whose breast cancer has spread to other parts of the body.