Metastatic Breast Cancer Network (MBCN)

Genentech Breast Cancer Drug Denied Accelerated Approval

MBCN News — Thu, 09 Sep 2010 01:12:40 +0000

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

Within sight: the end of breast cancer

MBCN News — Fri, 20 Aug 2010 13:35:55 +0000

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 Ovarian Cancer National Alliance Appeal to FDA and Key Lawmakers on Avastin Issue

MBCN News — Sat, 14 Aug 2010 21:10:52 +0000

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noting that it is effective for some patients and warning of a chilling effect on new drug development if approval is withdrawn.

Protein Helps Predict Cancer Therapy-induced Heart Damage

MBCN News — Wed, 11 Aug 2010 04:03:09 +0000

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.

FDA Advisory Committee Recommends against Bevacizumab for Metastatic Breast Cancer

MBCN News — Wed, 28 Jul 2010 00:40:21 +0000

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

FDA Panel Nixes Bevacizumab for Breast Cancer

MBCN News — Wed, 21 Jul 2010 20:08:51 +0000

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.

New Bevacizumab Data Fails to Support Use in Advanced Breast CA

MBCN News — Sun, 18 Jul 2010 01:55:11 +0000

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.

Welch lends breast-cancer expertise to scientific council

MBCN News — Tue, 13 Jul 2010 18:59:49 +0000

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.

Metastases Kills 90 Percent Of All Cancer Patients But Only Five Percent Of Cancer Research Funds Are Spent On It

MBCN News — Tue, 13 Jul 2010 03:17:18 +0000

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]

NHS regulator rejects breast cancer treatment

MBCN News — Sat, 10 Jul 2010 22:03:38 +0000

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.