Tykerb

Lapatinib

• Brand(s): Tykerb
• Dosage Form/Strength: 250 mg tablet
• Effective date: November 14, 2011

For the second-line treatment of HER2-positive metastatic breast cancer when used in combination with chemotherapy after previous exposure to trastuzumab-based treatments.

For the treatment of HER-2 positive metastatic breast cancer when used in combination with chemotherapy after use of trastuzumab in patients who have an adverse drug reaction or contraindication to trastuzumab therapy.

Lapatinib will not be considered in patients who meet the following exclusions:

• Lapatinib (Tykerb) will not be funded in combination with trastuzumab (Herceptin) for second-line HER-2 positive metastatic breast cancer.
• Patients who have progressed while on trastuzumab (Herceptin) for second-line treatment of HER-2 positive metastatic breast cancer, will not be eligible for funding of lapatinib (Tykerb)
• Lapatinib (Tykerb) will not be funded in the adjuvant setting.

Dosing schedule:
1250 mg (5 tablets) once daily in combination with capecitabine for days 1 to 14 (in a 21-day cycle) until disease progression, unacceptable toxicity, or withdrawal of consent

Note: Funding of second-line lapatinib for HER-2 positive metastatic breast cancer will be discontinued upon evidence of disease progression

Duration of Approval: 6 Months

Renewal will be considered for lapatinib until there is evidence of disease progression at which point the drug should be discontinued.

Duration of Approval: 6 Months

EAP Drug Request Form:

Standard Form for EAP Drug Requests