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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