Tukysa FDA Approval History
Last updated by Judith Stewart, BPharm on Jan 24, 2023.
Tukysa (tucatinib) is a kinase inhibitor used for the combination treatment of HER2-positive breast cancer and RAS wild-type HER2-positive colorectal cancer.
- Tukysa is indicated:
- in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.
- in combination with trastuzumab for the treatment of adult patients with RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
- Tukysa contains tucatinib, which is a tyrosine kinase inhibitor of HER2. It works by inhibiting the growth of HER2 expressing tumors. The combination of tucatinib and trastuzumab demonstrated increased anti-tumor activity compared to each of the drugs used individually.
- Tukysa tablets are administered orally, twice daily.
- Warnings and precautions associated with Tukysa include severe diarrhea, hepatotoxicity, and embryo-fetal toxicity.
- Common adverse reactions with Tukysa in combination with trastuzumab and capecitabine in patients with metastatic breast cancer include diarrhea, palmar-plantar erythrodysesthesia, nausea, hepatotoxicity, vomiting, stomatitis, decreased appetite, anemia, and rash.
Common adverse reactions with Tukysa in combination with trastuzumab in patients with unresectable or metastatic colorectal cancer include diarrhea, fatigue, rash, nausea, abdominal pain, infusion related reactions, and pyrexia.
Development timeline for Tukysa
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