FDA Backs Drug for Early-Stage Breast Cancer

by William White | September 13, 2013 2:09 pm

A federal advisory committee to the Food and Drug Administration (FDA) voted 13 to 0[1], with one member of the panel not voting, to approve a drug for use on early-stage breast cancer on Thursday.

The panel agreed that Perjeta, a Genentech drug that is used on late-stage breast cancer, could also be used to treat early-stage breast cancer. The FDA has yet to officially approve the drug, but officials claim it will likely approve it. Perjeta is only approved to treat HER2-positive tumors, which is about 20% of breast cancer tumors. Genentech estimates that 15,000 American woman a year will be eligible for treatment with Perjeta. Approval of Perjeta could possibly allow women to obtain reimbursement from insurance companies for the treatment, as well as allowing them access to the drug earlier, reports The New York Times.

The FDA is expected to officially make a decision[2] concerning Perjeta’s use on early-stage breast cancer by Oct. 31.

  1. voted 13 to 0: http://www.nytimes.com/2013/09/13/business/panel-backs-drug-for-early-stage-breast-cancer.html
  2. officially make a decision: http://www.cbsnews.com/8301-204_162-57602733/fda-panel-supports-perjeta-for-early-stage-breast-cancer/

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