(dailyRx)
Even though a U.S. Food and Drug Administration (FDA) panel has voted to no longer approve Avastin (bevacizumab) for treating late-stage breast cancers, Medicare has indicated it will continue to pay for the drug.
A spokesman said that the FDA’s ruling doesn’t affect Medicare policies.
A panel of cancer experts voted this week to change the labeling on Avastin so that it’s not approved for treating metastatic breast cancer. This upholds a ruling the FDA made late last year following four studies which showed the drug didn’t extend the lives of breast cancer patients.
The drug’s manufacturer, Roche Holdings, appealed that decision, and an unprecedented two-day hearing was held earlier this week.
The FDA Commissioner will make a final decision on the future of Avastin as a breast cancer treatment.
Physicians are still able to prescribe Avastin for breast cancer, regardless of what regulators decide. However, there is a concern that a change in labeling may influence Medicare and private insurers not to pay its sizeable pricetag – some $88,000 annually.
Genentech, Roche’s U.S. unit, plans to continue providing free access to Avastin to patients who don’t have insurance or whose insurance drops covering, a unit spokesman said.
The medication is still approved to treat a number of late-stage cancers, including colorectal, kidney and lung. Avastin is also used as a treatment for a form of brain cancer, glioblastoma multiforme.
Breast Cancer
In the United States, one out of every eight women will be diagnosed with breast cancer sometime in her life. In 2010, there were over 250,000 new cases of breast cancer in women, and the number is rising. While treatment is improving, almost 40,000 women still died from breast cancer during 2009. However, there are still 2.5 million women in the US who are survivors.
Breast cancer, like any other cancer, is malignant, uncontrolled growth of breast tissue, usually from the tissue that lines the milk ducts (ductal carcinoma) or the tissue that makes the milk (lobular carcinoma). When cancer has not invaded other parts of the breast, it is referred to as in situ. (ex. Ductal carcinoma in situ). Breast cancers are also defined by their genes and hormone sensitivity. Some grow in response to the presence of estrogen, and area called ER+. Others have specific genes that make the cancer more aggressive, such as the gene HER2. These are important distinctions that direct treatment and prognosis.