Breast cancer, the most common cancer among women worldwide, kills nearly 400,000 women every year. More than one million new cases are diagnosed yearly.
According to Sandhya Pruthi, MD, assistant professor of medicine at Mayo Clinic College of Medicine in Rochester, Minn. , “HER2-positive breast cancer is a breast cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2), which promotes the growth of cancer cells. In about 1 of every 5 breast cancers, the cancer cells make an excess of HER2 due to a gene mutation.”
Swiss drug maker Roche Holding AG reports they have filed an application to the US Food and Drug Administration (FDA) for a new cancer drug for HER2-positive breast cancer patients with advanced breast cancer.
“The drug, known as trastuzumab-DM1, or T-DM1, is the first conjugated monoclonal antibody to be reviewed by the FDA and has realistic chances to be approved in some breast cancer patients by the regulator given the medicine’s strong trial results”, Roche analysts said.
“While we’ve made great strides in treating HER2-positive breast cancer, there is a group of people whose breast cancer will come back after many treatments, leaving them with very limited options,” said Roche’s chief medical officer Hal Barron. “Data from studies have shown that T-DM1 shrank tumors in these people, so we are excited to have submitted this application to the FDA in hopes offering a potential new medicine to people with this type of breast cancer.”
If approved, based on the Phase II studies, the drug’s launch could take place as early as the beginning of 2011. Roche will still conduct Phase III studies.
Dr. Pruthi adds, “Routine testing for HER2 is recommended for most women diagnosed with breast cancer because the results may affect treatment recommendations and decisions. Whenever breast cancer recurs or spreads, the cancer cells should be retested for HER2 as well as for hormone receptor status, as these can change from the original cancer in up to 20 to 30 percent of cases.”
Mayo Clinic, suggests this three-tiered approach for early breast cancer detection:
1. Breast self-exam to identify breast abnormalities and allow a woman to become familiar with her breasts so that she can tell her doctor about any changes.
2. Clinical breast exam performed by a health care provider and recommended annually beginning at age 40.
3. Screening mammography beginning at age 40
If you or someone you love cannot afford a mammogram, the FDA’s website has a list of free mammograms across the US: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMQSA/mqsa.cfm
To donate a free mammogram: www.thebreastcancersite.com