Seagen gains accelerated approval for Tukysa from FDA

On Thursday, the US Food and Drug Administration (FDA) granted accelerated approval for Seagen’s (Nasdaq: SGEN) Tukysa (tucatinib) in combination with trastuzumab for RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.

This is the first FDA-approved treatment in HER2-positive metastatic colorectal cancer. The FDA previously granted Breakthrough Therapy designation and priority review for Tukysa in this setting, Seagen noted.

“Historically, patients with HER2-positive metastatic colorectal cancer who have progressed following frontline therapy have had poor outcomes,” said Dr John Strickler, associate professor of medicine, Duke University Medical Center, and lead investigator for the MOUNTAINEER trial, adding: “The FDA approval of a chemotherapy-free combination regimen that specifically targets HER2 is great news for these patients.”