Seattle Genetics gains early FDA approval for breast cancer drug Tukysa

18 April 2020

US biotech Seattle Genetics (Nasdaq: SGEN) closed up 2.6% at $136.87 on Friday after it revealed that the US regulator had granted approval for its new cancer drug, well ahead of the expected action date of August 20, 2020.

The US Food and Drug Administration granted approval to Tukysa (tucatinib) tablets in combination with trastuzumab and capecitabine for adult patients with advanced unresectable (cannot be surgically removed) or metastatic HER2-positive breast cancer, including patients with brain metastases (disease that has spread to the brain), who have received one or more prior anti-HER2-based regimens in the metastatic setting.

"We recognize that patients with cancer constitute a vulnerable population at risk of contracting the coronavirus disease," said Dr Richard Pazdur, director of the FDA's Oncology Center of Excellence, in a press release., adding: "We remain steadfast in our commitment to patients with cancer and doing everything we can to expedite oncology product development."

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