FDA accepts Seattle Genetics’ tucatinib application, action date August 20

Under Priority Review status and its Real-Time Oncology Review and Orbis Pilot Programs, the FDA accepts Seattle Genetics’ (NASDAQ:SGEN) marketing application for the combination of tucatinib and Roche’s (OTCQX:RHHBY) Herceptin (trastuzumab) and Xeloda (capecitabine) for the treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received at least three prior HER2-directed agents separately or in combination, in the neoadjuvant, adjuvant or metastatic setting.

The agency’s action date is August 20.

Tucatinib is an oral small molecule tyrosine kinase inhibitor highly selective for HER2.

https://seekingalpha.com/news/3541692-fda-accepts-seattle-genetics-tucatinib-application-action-date-august-20