Tukysa™

Drug - Tukysa™ (tucatinib) [Seattle Genetics, Inc.]

September 2020

Therapeutic Area - Oncology, Oral, Breast Cancer

Initial approval criteria

• Patient is ≥ 18 years old AND
• Patient’s disease is human epidermal growth factor receptor (HER2-positive)* AND
• Patient is NOT taking any of the following potential agents that interact with tucatinib:
  • Coadministration with strong CYP3A inducers (e.g., rifampin, carbamazepine, St. John’s wort) OR
  • Coadministration with moderate CYP2C8 inducers (e.g. rifampin) OR
  • Coadministration with strong CYP2C8 inhibitors (e.g., paclitaxel, repaglinide; if therapy is unavoidable, the patient will be monitored closely for adverse reaction and/or dose modifications) OR
  • Coadministration with CYP3A substrates with a narrow therapeutic index (e.g., amitriptyline, carbamazepine; if therapy is unavoidable, the patient will be monitored closely for adverse reaction and/or dose modifications) OR
  • Coadministration with P-gp substrates with a narrow therapeutic index (e.g., colchicine, digoxin, phenytoin; if therapy is unavoidable, the patient will be monitored closely for adverse reaction and/or dose modifications) AND
• The patient has a diagnosis of breast cancer, and the patient meets the following requirements:
  • Patient’s disease is unresectable, locally advanced, or metastatic AND
  • Used as subsequent therapy in combination with trastuzumab and capecitabine AND
  • Patient has been previously treated with the following anti-HER2 directed therapies: trastuzumab, pertuzumab, and ado-trastuzumab emtansine; alone or in combination with at least 1 in the metastatic setting OR
  • Patient has neurologically stable brain metastases related to breast cancer AND
  • Patient does NOT have leptomeningeal disease AND
  • Tucatinib is used as subsequent therapy in combination with trastuzumab and capecitabine AND
• Patient has been previously treated with the following anti-HER2 directed therapies: trastuzumab, pertuzumab, and ado-trastuzumab emtansine, alone or in combination with at least 1 in the metastatic setting
• Initial approval is for 6 months

Renewal criteria

• Patient must continue to meet the above initial criteria, such as concomitant therapy requirements (not including prerequisite therapy) and performance status AND
• Disease response with treatment, as defined by stabilization of disease or decrease in size of tumor or tumor spread AND
• Absence of unacceptable toxicity from the drug (e.g., hepatotoxicity [severe changes in liver function tests], severe diarrhea)
• Renewal approval is for 6 months

* HER2 overexpression must be confirmed as follows:

• Immunohistochemistry (IHC) assay 3+ OR
• Dual-probe in situ hybridization (ISH) assay HER2/CEP17 ratio ≥ 2 AND average HER2 copy number ≥ 4 signals/cell OR
• Dual-probe in situ hybridization (ISH) assay AND concurrent IHC indicating one of the following:
  • HER2/CEP17 ratio ≥ 2 AND average HER2 copy number < 4 signals/cell AND concurrent IHC 3+ OR
  • HER2/CEP17 ratio < 2 AND average HER2 copy number ≥ 6 signals/cell AND concurrent IHC 2+ or 3+ OR
  • HER2/CEP17 ratio < 2 AND average HER2 copy number ≥ 4 and < 6 signals/cell AND concurrent IHC 3+

Quantity limits

• 120 tablets/30 days

Questions?

MHCP Provider Call Center 651-431-2700 or 800-366-5411