Seagen's Tukysa label expanded; ADARx gets $46M script for RNA trial
Seagen just scored another approval for one of its lead drugs.
Tukysa won accelerated approval from the FDA on Thursday to be used in combination with Roche’s Herceptin for patients with a specific type of HER2-positive colorectal cancer. This is the first FDA-approved treatment in HER2-positive metastatic colorectal cancer, Seagen said in a statement.
FDA, which had given Tukysa (tucatinib) breakthrough therapy designation and priority review in this indication, said that it was approved based on a readout from a Phase II trial that saw a 38% overall response rate in 84 patients, with three complete responses and the median duration of response being 12.4 months.
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