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...
