Seagen: FDA To Review SNDA For Tucatinib In Combination With Trastuzumab

Seagen Inc. (SGEN) said FDA has accepted for Priority Review the supplemental New Drug Application seeking accelerated approval for TUKYSA in combination with trastuzumab
for adult patients with HER2-positive colorectal cancer who have received at least one prior treatment regimen for unresectable or metastatic disease. The sNDA submission is based on the results of the phase 2 MOUNTAINEER trial. The FDA has set a target action date of January 19, 2023.

In February 2022, Seagen initiated the global phase 3 MOUNTAINEER-03 clinical trial. It is intended to serve as a confirmatory trial in the U.S. and to support global filings.

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