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Seattle Genetics breast cancer therapy gets FDA breakthrough-therapy tag


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Seattle Genetics breast cancer therapy gets FDA breakthrough-therapy tag

The U.S. Food and Drug Administration granted breakthrough-therapy designation to Seattle Genetics Inc.'s medicine tucatinib in combination with other drugs to treat certain patients with breast cancer.

The Bothell, Wash.-based biotechnology company said the status was granted to tucatinib in combination with trastuzumab, sold by Roche Holding AG as Herceptin, and capecitabine, a drug also marketed by Roche as Xeloda. The combination is being evaluated to treat patients with HER2-positive breast cancer whose disease has spread to nearby tissue or lymph nodes and cannot be surgically removed or has spread to other parts of the body.

Seattle Genetics said in a Dec. 17 press release that the FDA's designation was backed by data from a phase 2 trial called Her2climb, which showed that the tucatinib combination was better than trastuzumab and capecitabine alone in treating patients with this type of breast cancer.

The company plans to file for approval of the combination by the first quarter of 2020.

Breakthrough-therapy designation expedites the development and review of medicines for treating serious or life-threatening conditions.

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