Seagen (NASDAQ:SGEN) on Monday said its supplemental new drug application (sNDA) for the accelerated approval of its inhibitor Tukysa in combination with monoclonal antibody trastuzumab to treat colon cancer had been accepted for priority review by the U.S. FDA.
The FDA is set to decide on the sNDA by Jan. 19, 2023, or the so-called Prescription Drug User Fee Act date.
The exact indication for which SGEN is seeking approval is 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.
"There are currently no FDA-approved therapies for metastatic colorectal cancer that specifically target HER2," SGEN senior VP and head of late-stage development Marjorie Green said in a statement.
The FDA's priority review process was created to speed up the approval of treatments for serious conditions that can be potentially much better than standard treatments.
SGEN has partnered with U.S.-pharmaceutical giant Merck (MRK) for the commercialization of Tukysa in regions outside of the U.S., Canada and Europe.