Seattle Genetics Win Early US FDA Approval For Tukysa, Plans Rapid Launch

Seattle Genetics Inc. plans to rapidly launch Tukysa (tucatinib) following the 17 April US Food and Drug Administration approval of its breast cancer drug – a decision that came four months before the new drug application’s action date under the agency’s real-time oncology review pilot program. It also was the first drug approved under Project Orbis, a collaborative effort between multiple international regulators to simultaneously review new oncology drugs.

Tukysa, a tyrosine kinase inhibitor of the HER2 protein, was approved in combination with Herceptin (trastuzumab) and capecitabine to treat advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting