NEW YORK – Seagen on Monday said it will seek accelerated approval from the US Food and Drug Administration for Tukysa (tucatinib) in combination with Genentech's Herceptin (trastuzumab) as a treatment for metastatic HER2-positive colorectal cancer.
The company said it will discuss with the FDA plans to file a supplementary new drug application containing data from the Phase II MOUNTAINEER trial, which found a 38 percent confirmed objective response rate among 117 previously treated metastatic HER2-positive colorectal cancer patients on Tukysa and Herceptin. The median duration of response on the combination treatment was 12.4 months.
Seagen said it will present full data from the MOUNTAINEER trial at the European Society for Medical Oncology World Congress on gastrointestinal cancer in June and discuss the data with regulators outside the US. Merck, which commercializes Tukysa in Asia, the Middle East, Latin America and other regions outside of the US, Canada, and Europe, will discuss the trial results with regulators in its territories.
Tukysa is approved in the US, UK, and Europe in combination with Herceptin and chemotherapy for the treatment of advanced unresectable or metastatic HER2-positive breast cancer. US and European regulators both granted approval for this indication in 2020, and the UK approved the drug earlier this year.
Seagen, based in Bothell, Washington, is also exploring Tukysa in other settings, including as an adjuvant treatment for HER2-positive breast cancer, in second-line HER2-positive breast and gastroesophageal cancer, and in solid tumors with HER2 alterations.