Tucatinib Plus Trastuzumab Approved for Colorectal Cancer

The FDA has granted accelerated approval to tucatinib (Tukysa®, Seagen, Inc.) with trastuzumab for rat sarcoma (RAS) wild-type human epidermal growth factor receptor 2 (HER2)–positive unresectable or metastatic colorectal cancer (CRC) that has progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. "Patients with chemotherapy-refractory HER2-positive metastatic colorectal cancer receive limited clinical benefit with currently available therapies," said John Stric...

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Tucatinib Approved: Metastatic HER2-Positive Breast Cancer

The FDA has now approved tucatinib (TukysaTM, Seattle Genetics) in combination with trastuzumab and capecitabine for adults with unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer, previously treated with at least one anti-HER2-based regimen in the metastatic setting. The tucatinib indication includes patients with brain metastases. The approval for tucatinib, a highly selective inhibitor of the HER2 tyrosine kinase, is based on data from HER2CLIMB ...

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