New breast cancer drug approved by the FDA
Ellence is first therapy for node-positive cancer
Pharmacia & Upjohn in Peapack, NJ, recently received approval from the Food and Drug Administration (FDA) in Rockville, MD, for its anti-cancer agent Ellence (epirubicin hydrochloride injection) as a component of adjuvant therapy following resection of early breast cancer that has spread to the lymph nodes under the arm. It is the first chemotherapy agent approved by the FDA for the adjuvant treatment of node-positive early breast cancer.
The approval of Ellence was based in part on a Canadian clinical study that found a combination of drugs containing Ellence reduces the risk of cancer recurrence and the risk of death significantly more than other commonly used therapies in women with axillary node positive early breast cancer.
Canadian researchers found that women treated with a drug combination including Ellence (cyclophosphamide, epirubicin, fluorouracil, known as CEF) survive relapse-free for five years, compared with 53% of women treated with the more commonly used CMF (cyclophosphamide, methotrexate, flourouracil).
Researchers say data demonstrate that use of Ellence in women with early-stage breast cancer reduces the risk of the cancer returning by 19% and the risk of death by 29%. Side effects of Ellence therapy are similar to those of other chemotherapies. They include the following:
• hair loss;
• nausea;
• vomiting;
• mouth sores;
• low white blood cell count.
(For more information, visit www.pnu.com. See also: J Clin Oncol 1998; 16:2,651-2,658 and 1990 8:1,483-1,496.)
You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content