Seattle Genetics nabs accelerated review in U.S. for HER2+ breast cancer

The FDA designates Seattle Genetics’ (SGEN +0.1%) tucatinib, combined with Roche’s (OTCQX:RHHBY +0.6%) Herceptin (trastuzumab) and chemo agent capecitabine, a Breakthrough Therapy for the treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including those with brain metastases, who have been treated with trastuzumab, pertuzumab, and T-DM1.

Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.

Tucatinib is a tyrosine kinase inhibitor highly selective for HER2 while avoiding significant inhibition of EGFR (associated with significant toxicities).

The company expects to file a U.S. marketing application next quarter.

https://seekingalpha.com/news/3527131-seattle-genetics-tucatinib-nabs-accelerated-review-in-u-s-for-her2-breast-cancer