​FDA Issues Positive Review On Roche Breast Cancer Drug

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September 10, 2013

The FDA has issued a positive review of Roche, a new breast cancer drug, that could soon become the first pharmaceutical option for treating the earliest stages of the disease, according to documents posted on the government agency’s website.

Scientists said women who received participated in a recent study to treat the disease had significantly fewer tumors 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 Roche’s Genentech unit is now seeking approval to use the drug at a much earlier stage of the disease: after diagnosis and before surgery to remove the tumor.

Surgery to remove tumors 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 tumors to make them easier to remove, or eliminate the need for surgery altogether.

On Thursday, the FDA will ask an outside panel of cancer specialists whether Perjeta’s benefits outweigh its risks for treating early-stage breast cancer. Among other questions, the experts will be asked whether the preliminary results reported by Genentech are likely to result in longer overall survival for patients. The government agency isn’t required to follow the group’s advice, though it often does.

The panel will review a 417-woman study comparing Perjeta in different combinations against older breast cancer treatments. When Perjeta was combined with Herceptin, another Genentech drug, and standard chemotherapy, 39 percent of women saw their cancer reach undetectable levels. Only 21 percent of women experienced the same results from taking Herceptin and chemotherapy .

Last year the FDA released guidelines for studying breast cancer drugs in the pre-surgical setting, with the aim of accelerating approval of promising therapies. Perjeta is the first drug to undergo FDA review since those recommendations were released. If approved, it could encourage more drugmakers to study cancer drugs for early-stage use.