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FDA: Roche drug works in early-stage cancer

Published: Tuesday, Sept. 10, 2013 5:41 p.m. CST

WASHINGTON (AP) – The Food and Drug Administration has issued a positive review of a breast cancer drug from Roche that soon could become the first pharmaceutical option approved for treating early-stage disease before surgery.

FDA scientists said women who received the drug Perjeta as initial treatment for breast cancer were more likely to be cancer-free at the time of surgery than women who received older drug combinations. Although the results come from mid-stage trials of the drug, FDA scientists recommended accelerating approval of the drug – a step reserved for groundbreaking drugs to treat life-threatening diseases.

Perjeta was first approved last summer to treat women with a subtype of breast cancer that already has spread. But Roche’s Genentech unit now is seeking approval to use the drug at a much earlier stage of the disease: after diagnosis and before surgery to remove the tumor.

The FDA is scheduled to make a decision on whether to approve Perjeta for early-stage breast cancer by Oct. 31.

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