Lenvima

Lenvatinib

• Brand(s): Lenvima
• Dosage Form/Strength: 4 mg, 10 mg capsules (packaged as 8mg, 10mg, 14mg, 18 mg, 20 mg, and 24 mg daily dose cartons.
• Updated March 5, 2020

For the treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid cancer (DTC) who meet ALL the following criteria:

1. Papillary or Follicular subtypes of DTC that are histologically or cytologically confirmed; AND

2. Thyroid cancer is refractory or resistant to radioactive iodine; AND

3. DTC shows evidence of disease progression within the past 13 months; AND

4. Patient has good performance status with ECOG less than or equal to 2; AND

5. Lenvatinib is being used as monotherapy

Exclusion criteria:

• Patients with anaplastic or medullary thyroid cancer
• Patients who have received more than one prior therapy with a tyrosine kinase inhibitor

Duration of Approval: 1 Year

Renewal of funding will be considered until a patient progresses on treatment or develops unacceptable toxicity to Lenvatinib.

Duration of Approval: 1 Year

For the treatment of unresectable advanced¹ hepatocellular carcinoma (HCC) in adult patients who meet ALL the following criteria prior to starting treatment with Lenvatinib:

1. Patient is 18 years of age or older; AND

2. Lenvatinib will be used as monotherapy for HCC; AND

3. Patient has good performance status with Eastern Cooperative Oncology Group (ECOG) Performance status less than or equal to 2; AND

4. Has a Child-Pugh class A liver function.

¹Patients with Stage B HCC, based on the Barcelona Clinic Liver Cancer (BCLC) Staging System will be considered for lenvatinib if they have progressed on transarterial chemoembolization (TACE). Case-by-case consideration will be provided for Stage B HCC patients who are not suitable for the TACE procedure. In such situations, please provide additional information to support why the patient is not suitable for TACE.

Exclusion Criteria: Patients meeting any of the following criteria will not be funded.

• Patients with Child-Pugh score greater than 6 (i.e., Child-Pugh class B or C) will not be funded.
• Patients who have progressed on sorafenib for HCC will not be funded for Lenvatinib

Only one of sorafenib or lenvatinib for the treatment of HCC will be funded in the first line. Patients will be permitted to switch from sorafenib to lenvatinib if they experience intolerance and have not progressed on sorafenib.

Recommended Dosage:
The recommended daily dose of lenvatinib is 8mg once daily for patients with a body weight of less than 60kg and 12 mg once daily for patients with a body weight of ≥60 kg

Renewal Criteria:
Renewals will be considered for patients who have not experienced unacceptable toxicities to lenvatinib or until disease progression.
Please provide radiographic results, scan results or both indicating no progression. Progression evaluation will be in accordance with modified Response Evaluation Criteria in Solid Tumors (mRECIST) or RECIST 1.1 criteria.

Approval duration for initials and approvals: 3 months

EAP Drug Request Form:

Standard Form for EAP Drug Requests