MONDAY, April 20, 2020 (HealthDay News) -- The U.S. Food and Drug Administration announced Friday the approval of Tukysa (tucatinib) in combination with trastuzumab and capecitabine for treatment of advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer.
Tukysa, a kinase inhibitor, is indicated for patients who have already received treatment with at least one anti-HER2-based regimen in the metastatic setting. Approval was based on results of the HER2CLIMB clinical trial, which enrolled 612 patients with HER2-positive advanced unresectable or metastatic breast cancer who had previously received treatment with trastuzumab, pertuzumab, and ado-trastuzumab emtansine (T-DM1). Forty-eight percent of patients had brain metastases at trial start.
Median progression-free survival was 7.8 and 5.6 months in patients who received Tukysa, trastuzumab, and capecitabine and those who received placebo, trastuzumab, and capecitabine, respectively. The corresponding median overall survival was 21.9 and 17.4 months. Among patients with brain metastases at baseline, median progression-free survival was 7.6 and 5.4 months for those who received Tukysa, trastuzumab, and capecitabine and those who received placebo, trastuzumab, and capecitabine, respectively.
Commonly reported side effects were diarrhea, palmar-plantar erythrodysesthesia, nausea, fatigue, hepatotoxicity, vomiting, stomatitis, decreased appetite, abdominal pain, headache, anemia, and rash. Potential serious side effects with Tukysa include severe diarrhea associated with dehydration, acute kidney injury, and death.
Approval was granted to Seattle Genetics. The approval was part of Project Orbis, which provides a framework for simultaneous submission and review of oncology drugs among international health authorities.