Lenvima

Lenvatinib

• Brand(s): Lenvima
• Dosage Form/Strength: 4 mg, 10 mg capsules (packaged as 4 mg, 8 mg, 10 mg, 14 mg, 20 mg, and 24 mg daily dose cartons.) (Note: 18 mg is not publicly funded)
• Updated March 5, 2020; Updated September 1, 2023 for 2 new indications

Initiation criteria for differentiated thyroid cancer (DTC):

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

Initiation criteria for advanced hepatocellular carcinoma (HCC)

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 <60kg>

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

Initiation criteria for metastatic renal cell carcinoma (mRCC)

Lenvatinib will be funded for the treatment of advanced (not amenable to curative surgery or radiation) or metastatic renal cell carcinoma (mRCC) in patients who meet ALL the following criteria;

1. 18 years of age or older;
   AND
2. Has a confirmed diagnosis of advanced (not amenable to curative surgery or radiation) or metastatic renal cell carcinoma;
   AND
3. Patient is not a candidate for curative surgery or radiation;
   AND
4. Patient’s disease in any international mRCC database consortium (IMDC) risk group category (Note 1);
   AND
5. Is using lenvatinib as first line in a patient who has not received a prior systemic therapy for advanced or metastatic renal cell carcinoma;
   AND
6. Lenvatinib is used in combination with pembrolizumab;
   AND
7. Patient has good performance status;
   AND
8. Prescribed by an expert in the diagnosis and management of renal cell carcinoma.

Note:

1. If an IMDC risk classification cannot be provided, the Memorial Sloan Kettering Cancer Center (MSKCC) risk group categories to confirm that the patient’s disease is in any MSKCC risk group category may be used.
2. The Ministry will fund only one of pembrolizumab with lenvatinib or pembrolizumab with axitinib for mRCC.
3. Patients with stable or treated central nervous system (CNS) metastases may be considered provided all other eligibility criteria are met.

Exclusions:

Patients meeting any of the following criteria are not eligible for funding of lenvatinib.

1. Using in combination with another anticancer drug other than pembrolizumab.

Renewal Criteria:

Renewal of funding will be considered until disease progression or development of unacceptable toxicities.

Recommended dose:

Lenvatinib: 20 mg orally daily modified as needed to manage adverse reactions.

Lenvatinib is continued as monotherapy following 35 cycles of pembrolizumab until disease progression or development of unacceptable toxicities.

Pembrolizumab is funded under the New Drug Funding Program (NDFP) and an application to NDFP will be required.

Pembrolizumab 2 mg/kg intravenously (IV) (up to a maximum of 200 mg) every 3 weeks OR Pembrolizumab 4 mg/kg IV (up to a maximum of 400 mg) every 6 weeks.

Up to a maximum of 2 years (up to 35 doses given every 3 weeks or 18 doses given every 6 weeks), whichever comes first.

Patients who complete 2 years of pembrolizumab without disease progression or recurrence on pembrolizumab may be considered for retreatment upon relapse and may receive up to an additional year of pembrolizumab, with or without lenvatinib, at the point of confirmed disease progression.

Approval Duration of initials and renewals: 1 year

Initiation criteria for the treatment of advanced, recurrent, or metastatic, proficient mismatch repair (pMMR) endometrial carcinoma

Lenvatinib will be funded for the treatment of advanced, recurrent, or metastatic, proficient mismatch repair (pMMR) endometrial carcinoma in patients who meet ALL the following criteria;

1. 18 years of age or older;
   AND
2. Has a confirmed diagnosis of advanced, recurrent, or metastatic endometrial carcinoma that is deemed to be proficient mismatch repair (pMMR);
   AND
3. Documentation that endometrial carcinoma is not microsatellite instability high (MSI-H) disease;
   AND
4. Documentation that endometrial carcinoma is not mismatch repair deficient (dMMR) disease;
   AND
5. Patient is not a candidate for curative surgery or radiation;
   AND
6. Lenvatinib will be used in combination with pembrolizumab (Note 1 and dosing recommendations);
   AND
7. Has experienced disease progression (must be radiographically confirmed) after 1 prior systemic regimen using a platinum-based chemotherapy regimen (Note 2);
   AND
8. Must have a good performance status;
   AND
9. Prescribed by an expert in the diagnosis and management of endometrial carcinoma.

Notes:

1. Patients who have developed unacceptable toxicities to pembolizumab may continue with lenvatinib monotherapy and vice versa.
2. Patients who have received more than one prior line of platinum-based chemotherapy that is not in the neoadjuvant or adjuvant treatment settings may be considered on a case-by-case basis.
3. Patients with carcinosarcoma (also referred to as malignant mixed Müllerian tumor) will be eligible for funding provided all other eligibility criteria are met.
4. Patients with stable or treated central nervous system (CNS) metastases may be considered.

Exclusions:

Patients meeting any of the following criteria are not eligible for funding of lenvatinib.

1. Patients with sarcoma (e.g., endometrial leiomyosarcoma, endometrial stromal sarcoma).
2. Using in combination with another anticancer drug other than pembrolizumab.

Renewal Criteria:

Renewal of funding will be considered until disease progression or development of unacceptable toxicities.

Recommended dose:

Lenvatinib: 20 mg orally daily modified as needed to manage adverse reactions.

Lenvatinib is continued as monotherapy following 35 cycles of pembrolizumab until disease progression or development of unacceptable toxicities.

Pembrolizumab is funded under the New Drug Funding Program (NDFP) and an application to NDFP will be required.

Pembrolizumab 2 mg/kg intravenously (IV) (up to a maximum of 200 mg) every 21 days (max of 35 cycles), or Pembrolizumab 4 mg/kg IV (up to a maximum of 400 mg) every 42 days (maximum of 18 cycles)

Patients who complete 2 years of pembrolizumab without disease progression may be considered for retreatment upon relapse and may receive up to an additional one year of pembrolizumab (i.e., 17 cycles if given every 3 weeks or 9 cycles if given every 6 weeks), with or without lenvatinib, at the point of confirmed disease progression

Approval Duration of initials and renewals: 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests