Roche breast cancer drug gets U.S. pre-surgery approval

Reuters

Sept 30 (Reuters) - U.S. health regulators expanded theapproval of Roche Holding AG's breast cancer drugPerjeta and will now allow its use to help shrink tumors priorto surgery, the Food and Drug Administration said on Monday.

The decision followed a 13-0 vote by an FDA advisory panelearlier this month in favor of the expanded approval.

Perjeta was originally approved in 2012 to treat patientswith advanced or late-stage HER2-positive breast cancer. It cannow be used prior to surgery in patients with HER2-positive,locally advanced, inflammatory or early-stage breast cancer whoare at high risk of having their cancer return or spread, theagency said.

"By making effective therapies available to high-riskpatients in the earliest disease setting, we may delay orprevent cancer recurrences," Dr. Richard Pazdur, director of theOffice of Hematology and Oncology Products in the FDA Center forDrug Evaluation and Research, said in a statement.

Under the expanded approval, Perjeta, known chemically aspertuzumab, would be used in combination with Roche's olderbreast cancer drug Herceptin and chemotherapy prior to surgery.

Herceptin has long been used to treat HER2-positive breastcancer to reduce the risk of disease recurrence. About 20percent of breast cancers have an abundance of the HER2 proteinand tend to be aggressive, faster growing cancers.

Following surgery, patients who had been treated withPerjeta should continue to take Herceptin for a year, the FDAsaid.

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