FDA Expands Use Of Breast Cancer Drug
The breast cancer drug Herceptin received expanded federal approval Thursday to include treatment of some women after they have undergone surgery.
In two clinical trials, women given the drug along with chemotherapy had fewer relapses in the three years after surgery — either to remove a lump or the whole breast — than those just given standard chemotherapy, the Food and Drug Administration said in announcing the additional approval. The drug is made by Genentech Inc. of South San Francisco, Calif.
In 1998, the FDA approved Herceptin to treat breast cancer after it had spread to other parts of the body. Thursday's approval expands its use to women with cancer in the breast or lymph nodes that has been surgically removed, the FDA said.
Only patients with HER-2 positive tumors, and who do have heart failure or a weak heart, should be given the drug, also known as trastuzumab,
The Early Show medical correspondent Dr. Emily Senay sat down with co-anchor Hannah Storm to talk about Herceptin:
Hannah Storm: What is this drug?
Dr. Emily Senay: The drug is Herceptin, a bioengineered medication that targets specific cancer cells that tend to be especially aggressive. These cells are called Her-2 positive cells, and they appear in 20 to 30 percent of all breast cancer patients.
Storm: What do studies indicate about the effectiveness of Herceptin?
Dr. Senay: A major study released late last year in the New England Journal of Medicine looked at Herceptin's effect on early stage cancers. The researchers found that women who received chemotherapy plus Herceptin following breast cancer surgery had only half as much risk of cancer recurrence as those treated with chemo alone. Those results got a lot of attention in the medical community.
Storm: Have studies also found a downside to Herceptin?
Dr. Senay: The biggest concern involves a potential effect on heart function. When it's prescribed for advanced breast cancers, Herceptin comes with a warning based on the experience of patients who have developed congestive heart failure, and significantly lower function in one of the chambers of the heart — the left ventricle. Herceptin is also associated with severe allergic reactions and respiratory distress — especially during the early stages of cancer treatment. Those minuses are undoubtedly a concern to the FDA as it considers possible approval for early stage cancer.
Storm: What else is out there now, for women with early stage breast cancers?
Dr. Senay: Chemotherapy is still very widely used. Medications that regulate the female hormone estrogen have also become effective treatment tools. Those drugs include Tamoxifen, Arimidex and Femara. If it's approved to treat early-stage cancers, Herceptin might be used in conjunction with those other treatments, or by itself, depending on the patient.
Storm: Not all breast cancers are alike, are they?
Dr. Senay: No they're not, and that's one reason why many cancer specialists wanted to see Herceptin get the expanded approval. The Her-2 positive cancers that Herceptin targets can develop — or recur — with frightening speed. The volatility of this form of the disease is one reason why researchers made a special effort to see if Herceptin is an option for early stage breast cancers.