Seagen Aims To Make Tukysa First Drug For HER2-Positive Colorectal Cancer

The Phase II MOUNTAINEER trial showed a benefit for patients with HER2-positive metastatic colorectal cancer treated with the tyrosine kinase inhibitor in combination with trastuzumab.

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Seagen hopes to be first to market with a HER2-targeted treatment for colorectal cancer • Source: Shutterstock

Seagen Inc. could be the first to bring a drug to market for HER2-positive metastatic colorectal cancer (mCRC) if the US Food and Drug Administration approves Tukysa (tucatinib) for the expanded indication based on positive Phase II data.

The company is poised to seek accelerated approval from the FDA for the drug in second-line HER2-positive mCRC based on the positive results of the MOUNTAINEER trial, detailed on 2 July at the European Society

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