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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June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.