Rozlytrek

Entrectinib

• Brand(s): Rozlytrek
• Dosage Form/Strength: 100 mg, 200 mg capsule
• Effective date: December 23, 2021

Initial Criteria:

For the treatment of locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) in patients who meet the following criteria:

1. Entrectinib is being used as the first-line oral treatment for a patient with ROS1-positive NSCLC¹; AND

2. Patient has good performance status; AND

3. Patient is using entrectinib as monotherapy.

¹Include the ROS1 laboratory report with the application.

Renewal Criteria:
Renewals will be considered until clinically meaningful disease progression or the patient has experienced unacceptable toxicity.

Exclusion Criteria:

• Entrectinib will not be funded as combination therapy with another treatment for the treatment of ROS1-positive NSCLC.
• Entrectinib will not be funded in patients who have previously experienced disease progression while on crizotinib for ROS1-positive NSCLC.

Notes:

1. Patients who have initiated on a first-line platinum-based doublet chemotherapy, chemotherapy-immunotherapy combination, or single agent immunotherapy and have not progressed, may be considered for entrectinib if they have not received an ROS-1 targeted treatment previously.

Approved Dose: Maximum of 600 mg orally once daily

Approval duration of Initials and Renewals: 1 year

Entrectinib

• Brand(s): Rozlytrek
• Dosage Form/Strength: 100 mg, 200 mg capsule
• Effective date: May 16, 2023

Rozlytrek for NTRK gene fusion tumours:

For the treatment of adult patients with unresectable locally advanced, or metastatic solid extracranial tumours in patients meeting ALL the following criteria:

1. Tumour is documented to have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation; AND

2. Has failed all standard treatment for their tumour site; AND

3. Where surgery is not an option as it may lead to substantial morbidity; AND

4. Patient has a good performance status (i.e. an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2); AND

5. Entrectinib should be administered as monotherapy

Exclusion: Entrectinib will not be funded in patients who have experienced disease progression on an NTRK inhibitor

Notes:

1. The patient’s NTRK gene fusion report must be submitted with the application.

2. The patient’s baseline radiographic evaluation (i.e., CT and/or MRI) should be provided on the initial funding application to EAP.

3. Reimbursement with entrectinib can include patients meeting the above initiation criteria who have brain metastases that are controlled or asymptomatic but entrectinib should not be initiated in patients who have primary CNS tumours.

Renewal Criteria:
Renewals will be considered in patients who have not experienced disease progression or unacceptable toxicities requiring discontinuation while on entrectinib.
Please provide radiographic and/or scan results indicating no progression with requests for renewal of funding.
Evaluation according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) or RECIST 1.1 criteria and Response Assessment in Neuro-Oncology for CNS tumours.

Approved dose: Up to 600 mg orally once daily

Approval duration of initials: 3 months

Approval duration of first renewal: 3 months

Approval duration of 2nd renewal: 6 months

Approval duration of 3rd and subsequent renewals: 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests