Interim results from a pivotal phase III study of the drug were recently described in the New England Journal of Medicine as “simply stunning” and “maybe even a cure” for the disease by Dr Gabriel Hortobagyi of the University of Texas Anderson Cancer Center in Houston.
However, an editorial in The Lancet has counseled that the evidence to support the effectiveness and safety of the drug is not yet complete, and that judgment on the drug should be suspended until it has completed the standard regulatory process.
“The best that can be said about Herceptin’s efficacy and safety for the treatment of early breast cancer is that the available evidence is insufficient to make reliable judgments. It is profoundly misleading to suggest, even rhetorically, that the published data may be indicative of a cure for breast cancer,” read the Lancet editorial.
The NHS has recently announced that it will be providing Herceptin to a number of women with early stage breast cancer despite the drug not yet being fully licensed.
Interim results from a pivotal phase III study suggested that the drug produced a 52% reduction in the risk of recurrence of an aggressive type of cancer classified as early-stage, operable human epidermal growth factor receptor 2 (HER2)-positive breast cancer.