FDA: Drug works in early-stage breast cancer patients

May be approved for use before surgery on tumors

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

In documents posted online, 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 midstage trials, 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 a subtype of breast cancer that has 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: after diagnosis and before surgery to remove the tumor.

Surgery to remove tumors is the first step in treating virtually all forms of cancer. If approved, Perjeta would be the first cancer drug approved for use as a pre-surgical step. Using cancer drugs before surgery is still experimental, but doctors hope that the approach could help shrink tumors to make them easier to remove. In some breast cancer cases, a tumor that is easier to operate on could allow women to keep their breasts, rather than having them surgically removed.

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.

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 alone. After drug treatment all the women received standard breast surgery to remove any cancerous tumors. Genentech says this surgery allowed researchers to confirm the presence or absence of cancer.

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 drugmakers to study cancer drugs for early use. "Despite advances in systemic therapy of breast cancer, there remains a need to expedite drug development and approval of highly effective therapies for patients with high-risk early-stage breast cancer," the FDA said.

Like Herceptin, Perjeta only works in a subset of about 20 percent of breast cancer patients who have tumors that overproduce a protein known as HER-2, which makes cancer cells rapidly divide and grow.

Breast cancer is the second most deadly form of cancer in U.S. women, and is expected to kill more than 39,000 Americans this year, according to the National Cancer Institute.

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