Inlyta

Axitinib

• Brand(s): Inlyta
• Dosage Form/Strength: 1 mg, 5 mg tablet
• Updated: March 15, 2021

For the treatment of advanced renal cell carcinoma (MRCC) in patients who meet the following criteria:

1. Axitinib is being requested as treatment for a patient with advanced renal cell carcinoma in one of the following settings:
   i) Axitinib is being used in treatment naïve patients as first line therapy in combination with pembrolizumab in patients with disease in any risk category (Note that in this first line setting, cabozantinib may be funded as second line following progression to axitinib);
   OR
   ii) As second line therapy after failure to sunitinib or pazopanib in patients with disease in any risk category (Note that in this second line setting, only one of axitinib OR nivolumab OR cabozantinib will be funded);
   OR
   iii) As third line therapy in patients in the intermediate or poor risk disease category who have progressed on combination therapy with ipilimumab and nivolumab in first line and sunitinib or pazopanib used in second line. (Note that in this third line setting, only one of axitinib or cabozantinib will be funded.)

2. Patients must have good performance status.

Notes:

• When used in combination with pembrolizumab in the first line setting, patients who are intolerant to pembrolizumab may stop pembrolizumab and continue treatment with axitinib as monotherapy until disease progression or development of unacceptable toxicities.
• When used in combination with pembrolizumab in the first line setting, patients experiencing disease progression or unacceptable toxicities may be considered for cabozantinib in second line, however, only two lines of treatment will be funded in this setting.
• Case-by-case consideration may be provided for patient with MRCC who have used and progressed on publicly funded older treatment regimens for MRCC such as everolimus, sorafenib, temsirolimus and/or interferons.

Funded Dosing Regimen: 5 mg twice a day. Dose may be adjusted based on individual response and tolerability.

Renewal Criteria: Renewals will be considered in patients who have not experienced disease progression or unacceptable toxicity while being treated with axitinib.

Approval duration of initials and renewals: 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests