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Seattle Genetics' New Drug Application for Tucatinib Accepted by FDA

NEW YORK – Seattle Genetics said on Thursday that the new drug application for its investigational agent tucatinib has been accepted by the US Food and Drug Administration.

The NDA is for the use of tucatinib in combination with chemotherapies capecitabine and trastuzumab (Genentech's Herceptin) to treat patients with locally advanced, unresectable, or metastatic HER2-positive breast cancer who have received at least three prior HER2-targeted therapies.

The intended use population includes patients whose cancers have metastasized to the brain. The FDA in 2017 granted tucatinib orphan drug designation for the treatment of breast cancer patients with brain metastases. The agency also granted the application priority review and is evaluating it under its Real-Time Oncology Review and Orbis Pilot Programs. Seattle Genetics is expecting an FDA decision by the end of August.

Tucatinib is a small molecule tyrosine kinase inhibitor that is highly selective for HER2. The application for tucatinib is supported by results from a randomized Phase II trial presented at the 2019 San Antonio Breast Cancer Symposium and published in the New England Journal of Medicine.

In the 612-patient trial, participants either received tucatinib and the chemotherapy combination, or only the chemotherapy combination. The two-year overall survival rate among those who received the tucatinib-containing regimen was 44.9 percent compared to 26.6 percent for patients in the comparator arm.