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FDA Panel Backs Wider Use of Breast Cancer Drug

Perjeta, which seems to shrink early stage tumors, might gain quick FDA approval

WebMD News from HealthDay

By Margaret Farley Steele

HealthDay Reporter

THURSDAY, Sept. 12 (HealthDay News) -- U.S. advisers endorsed on Thursday the broader use of a drug already used to treat advanced breast cancer that also appears to shrink early stage breast tumors.

This could potentially offer women with early stage breast cancer a first-of-its-kind treatment option and the hope of less-invasive surgical procedures.

If approved to treat early stage tumors, the drug, Perjeta, might result in less invasive surgical treatment for women with HER2-positive early stage breast cancer. In that role, Perjeta (pertuzumab) would be the first cancer-fighting drug approved as a first-step breast cancer therapy in the United States.

A U.S. Food and Drug Administration advisory panel voted 13 to 0 to recommend approval of the drug. The FDA is not bound to follow the recommendations of its advisory panels but it usually does.

An FDA report that was posted online Tuesday said the drug looked promising in trials. The report also said, however, that drug-related cardiac concerns will require additional research.

Advisory panel chairman Dr. Mikkael Sekeres, a professor of medicine at the Cleveland Clinic, called Thursday's vote "a historic moment," The Associated Press reported.

"We are supporting the movement of a highly active drug for metastatic breast cancer to the first-line setting, with the hope that women with earlier stages of breast cancer will live longer and better," Sekeres said.

The FDA is considering "fast-track" -- or accelerated -- approval of Perjeta, which is made by Roche's Genentech division, the AP reported. Fast-track approvals usually are given to drugs that haven't been thoroughly tested but show promising results in early trials.

Panel members insisted Thursday that Genentech carry out more trials to ensure that Perjeta will enable breast cancer patients to live longer, healthier lives, the news service said.

Genentech estimated that about 15,000 women with HER2-positive early stage breast cancer could receive early treatment with Perjeta each year, Bloomberg News reported.

Cancer specialists welcomed the news earlier this week of the preliminary results for Perjeta.

"This is tremendously exciting," said Dr. Amy Tiersten, associate professor in the division of hematology and medical oncology at Mount Sinai Medical Center in New York City.

"Pertuzumab was FDA approved in 2012 for the treatment of metastatic breast cancer when it was shown that it improved survival when added to standard regimens for HER2-positive metastatic breast cancer," Tiersten said. Metastatic breast cancer is cancer that has spread to other parts of the body.

"But the really exciting information is when this can be translated into earlier stages of disease, where we can completely eradicate the disease and cure more women," she said.

The preliminary trial under discussion showed that when Perjeta was added to standard pre-surgical regimens for HER2-positive breast cancer, the chance of finding no cancer after the treatment was nearly doubled, Tiersten said.

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