Lonsurf

¹As confirmed via imaging during/within 3 months of previously completed line(s) of therapy

Note: If patients have experienced intolerances with the prior lines of therapy, please provide a description of the intolerance including grade of toxicity which required the drug regimen to be stopped.

Renewal Criteria:
Renewals will be considered until radiographic evidence of disease progression or development of unacceptable toxicities.

Renewals should include radiographic reports and will be evaluated according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) or RECIST 1.1 criteria.

Approval duration of initial and renewals: 6 months.

Recommended dose:
35 mg/m²/dose twice daily on days 1 to 5 and days 8 to 12 of each 28-day cycle.
Dose adjustments based on individual safety and tolerability.

Metastatic colorectal cancer as combination therapy with bevacizumab

Initiation Criteria:

For the treatment of patients with previously treated metastatic colorectal cancer (mCRC) as combination therapy with bevacizumab in patients meeting ALL the following criteria:

1. 18 years of age or older;
   AND
2. Histologically confirmed adenocarcinoma with either unresectable or metastatic disease;
   AND
3. Disease progression or demonstrated intolerance to a maximum of 2 prior chemotherapy regimens for the treatment of advanced colorectal cancer that must include a fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, anti-VEGF monoclonal antibody and/or an anti-EGFR monoclonal antibody for RAS wild-type disease. (Note 1, 2 and 3);
   AND
4. Trifluridine-tipiracil must be used in combination with bevacizumab and the regimen should not be used with other systemic therapy for the treatment of mCRC;
   AND
5. Patient should have good performance status;
   AND
6. Prescribed by a clinician with expertise in the diagnosis and treatment of colorectal cancer.

Notes:

1. Patients who had received adjuvant/neoadjuvant chemotherapy and had recurrence during or within 6 months of completion could count the adjuvant/ neoadjuvant therapy as ONE of the maximum of 2 required prior chemotherapy regimens to qualify.
2. Patients who have experienced intolerances with the prior lines of therapy must provide a description of the intolerance including grade of toxicity which required the drug regimen to be stopped. Those who are not deemed to be a candidate for a required prior line of therapy must include the contraindication with the request.
3. Trifluridine-tipiracil used in combination with bevacizumab may be considered after third line treatment for mCRC on a case-by-case basis.
4. Patients may be eligible for trifluridine-tipiracil in combination with bevacizumab regardless of prior bevacizumab exposure.
5. Patients who were unable to receive bevacizumab in a prior line of therapy due to a contraindication may be eligible for trifluridine-tipiracil in combination with bevacizumab.
6. Patients with metastatic small bowel adenocarcinoma or appendiceal adenocarcinoma who meet all other funding criteria may be considered for trifluridine-tipiracil in combination with bevacizumab.
7. Patients meeting eligibility criteria for trifluridine and tipiracil who are microsatellite instability high/mismatch repair deficient and/or those with a BRAF V600E mutation would be considered eligible for treatment with trifluridine-tipiracil in combination with bevacizumab if all other lines of therapy have been used.
8. If bevacizumab is discontinued for reasons other than disease progression, trifluridine-tipiracil could be continued. If trifluridine-tipiracil are discontinued, then bevacizumab is to be discontinued.

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

• Funding is not provided in patients with symptomatic, unstable central nervous system (CNS) metastases.
• Funding is not provided in those requiring increasing doses of steroid to control CNS disease.

Renewal Criteria:
Combination therapy with bevacizumab may be continued until evidence of disease progression based on RECIST criteria as determined by radiographic scans or development of unacceptable toxicity.

Approved dose:
Recommended starting dose is 35 mg/m²/dose administered orally with water, twice daily on Days 1 to 5 and Days 8 to 12 of each 28-day cycle. This treatment cycle is repeated every 4 weeks.
Doses may be adjusted to manage adverse effects as aligned with the product monograph.

Approval duration: 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests