Seagen Gets FDA Accelerated Approval for Tukysa

By Kathryn Hardison

Seagen Inc. said Thursday that the Food and Drug Administration has granted accelerated approval to Tukysa(R)tucatinib in combination with trastuzumab for certain adult patients with colorectal cancer.

The biotechnology company said the accelerated approval is for patients with RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer.

Tukysa is approved under the FDA's Accelerated Approval Program based on tumor response rate and durability of response from the phase 2 MOUNTAINEER clinical trial, the company said. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

Seagen said this is the first FDA-approved treatment in HER2-positive metastatic colorectal cancer.

Write to Kathryn Hardison at [e-mail]

(END) Dow Jones Newswires

01-19-23 1449ET