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

(RTTNews) - 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.

For More Such Health News, visit rttnews.com.