TUKYSA

TUCATINIB

Manufacturer: SEAGEN INC.

Score: 141.0

Quick Summary

TUKYSA is a kinase inhibitor used in combination with trastuzumab and capecitabine for the 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. It is also used 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. The recommended dosage is 300 mg taken orally twice daily with or without food. TUKYSA can cause fetal harm when administered to a pregnant woman and has warnings for diarrhea and hepatotoxicity.

Key Clinical Findings and Indications

TUKYSA is used in combination with trastuzumab and capecitabine for the treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer
TUKYSA is used in combination with trastuzumab for the treatment of adult patients with RAS wild-type HER2-positive unresectable or metastatic colorectal cancer
The presence of HER2 protein overexpression and RAS wild-type in tumor specimens should be confirmed prior to the initiation of TUKYSA

Important Safety Information

Warning

TUKYSA can cause fetal harm when administered to a pregnant woman

Contraindications

Adverse Reactions

Diarrhea
Hepatotoxicity
Palmar-plantar erythrodysesthesia
Nausea
Vomiting
Stomatitis
Decreased appetite
Anemia
Rash

Dosing Recommendations

General Guidance

Dose reductions and modifications for adverse reactions are provided in Tables 1 and 2

Metastatic breast cancer

Adult Dose

300 mg taken orally twice daily with or without food

Pediatric Dose

Not established

Unresectable or metastatic colorectal cancer

Adult Dose

300 mg taken orally twice daily with or without food

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

TUKYSA can cause fetal harm when administered to a pregnant woman
Advise pregnant women and females of reproductive potential of the potential risk to the fetus

Nursing Mothers

Pediatric Use

The safety and effectiveness of TUKYSA in pediatric patients have not been established

Geriatric Use

In HER2CLIMB, 82 patients who received TUKYSA were ≥ 65 years, of whom 8 patients were ≥ 75 years
The incidence of serious adverse reactions in those receiving TUKYSA was 34% in patients ≥ 65 years compared to 24% in patients <65 years