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Roche application for breast cancer combo gets US FDA priority review

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Roche Holding AG's application for breast cancer drug Tecentriq was granted priority review by the U.S. Food and Drug Administration.

The Swiss drugmaker is seeking the U.S. regulator's approval for Tecentriq in combination with chemotherapy, specifically Celgene Corp.'s Abraxane, as an initial treatment for patients whose triple-negative breast cancer has spread across the body, could not be removed through surgery and expresses the PD-L1 protein.

Tecentriq is a PD-L1 inhibitor belonging to a class of tumor-targeting drugs known as checkpoint inhibitors. The therapies block proteins that stop the immune system from attacking cancer cells.

Roche's application is based on data from the phase 3 IMpassion130 study, which showed that the Tecentriq regimen improved survival in some patients with triple-negative breast cancer.

The U.S. FDA's priority review is given to therapies with the potential to improve on existing medicines in the treatment, prevention or diagnosis of a disease. The regulator is expected to decide on the combination's approval by March 12, 2019.

Tecentriq is being tested in seven different late-stage studies of both early and advanced triple-negative breast cancer.

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