The US Food and Drug Administration has issued a positive review of a breast cancer drug from Roche that could soon become the first pharmaceutical option for treating the earliest stages of the disease.
In documents posted online,FDA scientists said women who received the drug Perjeta to treat early-stage breast cancer had significantly fewer tumours than women who received older drug combinations. While the results come from mid-stage trials of the drug,FDA scientists recommended accelerating approval of the drug.
That step is reserved for groundbreaking drugs to treat life-threatening diseases.
Perjeta was first approved last summer to treat women with aggressive breast cancer that has already spread to other parts of the body. But Roches Swiss-based Genentech unit is now seeking approval to use the drug at a much earlier stage: after diagnosis and before surgery to remove the tumour.
Surgery to remove tumours is the first-line treatment for virtually all forms of cancer. If approved,Perjeta would be the first cancer drug approved for use as a pre-surgical step.
Early-stage cancer drugs are still experimental,but doctors hope the approach could help shrink tumours to make them easier to remove,or eliminate the need for surgery altogether.