The European Medicines Agency (EMA) has accepted for review Seattle Genetics’ (SGEN +0.4%)
marketing application seeking approval for tyrosine kinase inhibitor
tucatinib, combined with HER2/neu receptor antagonist trastuzumab and
chemo agent capecitabine, for adult patients with locally advanced
unresectable or metastatic HER2-positive breast cancer, including those
with brain metastases, who have received at least two prior lines of
anti-HER2 therapy.
The company filed its application in the U.S. a month ago under the FDA’s Real-Time Oncology Review Pilot Program.
https://seekingalpha.com/news/3536908-ema-accepts-seattle-genetics-tucatinib-application-for-her2-breast-cancer
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