WASHINGTON (September 10, 2013)—The U.S. Food and Drug Administration has issued a positive review of a breast cancer drug from Roche that could become the first pharmaceutical option for treating the earliest stages of the disease.
In documents posted online, FDA scientists say women who received the drug Perjeta developed significantly fewer tumors than women who received older drug combinations.
The results are unusual because the drug was used prior to surgery to remove the tumors.
Based on the findings, FDA scientists recommend accelerating approval of the drug, a step that is reserved for groundbreaking treatments for deadly diseases.
Perjeta was approved last summer to treat aggressive breast cancer that has spread to other parts of the body, but Roche now is seeking approval to use the drug at a much earlier stage of the disease.