In the US, colorectal cancer is the third leading cause of cancer-related deaths. Approximately 153,000 people will be diagnosed with colorectal cancer in the US this year alone, with an anticipated 52,550 deaths by the close of 2023. The rate of the disease is also increasing in younger adults. Around 22% of cases in the US are diagnosed at the advanced stage.
In what is the first FDA-approved treatment for HER2-positive metastatic colorectal cancer, Seagen’s combination regimen is approved for use in the second-line treatment setting and beyond. Accelerated Approval was given based on tumour response rate and durability of response from the phase 2 MOUNTAINEER clinical trial. Previously, the FDA granted TUKYSA Breakthrough Therapy Designation and Priority Review in the same setting.
