FDA Offers Fast-Track Approval to Herceptin  

Herceptin, the first monoclonal antibody treatment for some types of breast cancer, was approved recently by the FDA. The makers of Herceptin, Genentech, submitted Herceptin for approval on the "fast-track" to the FDA in May, and it was approved in September. This fast turnaround by the FDA was due in part to the hard work by breast cancer advocates. Prior to approval, Herceptin had been in clinical trials for five years and from December 1997 until full approval was available via a lottery as part of an expanded access trial. While some women waited on the lottery for access to Herceptin, over 500 women in the U.S. did start Herceptin treatment prior to approval.

Herceptin is indicated for use only in women with Stage IV breast cancer, whose tumors overexpresses HER2 (aka cerb-2, erb-2). The most promising application of Herceptin is in combination with Taxol, although some patients can be treated with Herceptin alone. Future clinical trials will probably include testing Herceptin for women with earlier stages of breast cancer and in combination with other chemotherapies.

Herceptin is given as a weekly infusion over 1/2 hour and is generally well-tolerated. The major side effects are fevers, chills or rigors with the initial infusion, which are usually transient. The one concerning side effect was an increase in cardiac toxicity especially when Herceptin was combined with Adriamycin, a standard chemotherapy known to increase cardiac toxicity. Because of this concern, the FDA requires extreme caution for the use of Herceptin in combination with Adriamycin or the other anthracycline containing chemotherapies.