Brukinsa

Renewal Criteria:

• Renewals will be considered in patients until disease progression or development of unacceptable toxicity.

• Response to therapy should be evaluated in accordance with IWWM response criteria.

Approved dose: 320 mg orally daily or 160 mg twice a day.

Initial and renewal approval period: 1 year

Zanubrutinib for chronic lymphocytic leukemia (CLL)

Initiation Criteria:

For the treatment of adult patients with chronic lymphocytic leukemia (CLL) who meet the following criteria:

1. Diagnosed with active disease according to one or more of the criteria from the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria;

   AND

2. Meets one of the following circumstances of use:

   i) First line use in a previously untreated patient who presents with one or more of the following cytogenic markers:

   • chromosome 17p deletion; OR

   • TP53 mutation, OR

   • unmutated immunoglobulin heavy chain variable region (IgHV);

   OR

   ii) Patient with relapsed or refractory CLL who has experienced disease progression on atleast one prior systemic therapy/regimen for CLL.*

   *A prior line of therapy should include a fludarabine-based regimen in fit patients.

   AND

3. Zanubrutinib will be used as monotherapy;

   AND

4. Patient has good ECOG performance status;

   AND

5. Prescribed by a clinician with expertise and experience in the treatment and management of CLL.

Renewal Criteria:

Renewals will be considered in patients until disease progression (as defined based on published iwCLL [2018] or a more recent iwCLL) or unacceptable toxicity.

Exclusion Criteria:
(Patients meeting the below will not be funded)

1. Patients who have experienced disease progression while being treated with another Bruton’s tyrosine kinase (BTK) inhibitor (e.g. ibrutinib, acalabrutinib) for the treatment of CLL.

2. Patients with prolymphocytic leukemia.

3. Patients with current or history of Richter's syndrome.

4. Patients with central nervous system (CNS) lymphoma or leukemia.

Notes:

1. The Ministry will not fund idelalisib following progression on a BTK inhibitor.

2. Patients may switch to zanubrutinib from another BTK inhibitor (e.g. ibrutinib, acalabrutinib) as long as they have not experienced disease progression on another BTK inhibitor. Please include the reasons for requesting the switch with the application (e.g. intolerances, contraindications, etc.).

3. Zanibrutinib may be considered in patients diagnosed with small lymphocytic lymphoma (SLL) on a case-by-case basis upon meeting the above treatment eligibility criteria for CLL.

Approved Dosage for Initials and Renewals:

320 mg orally daily or 160 mg twice daily with dose adjustments as necessary based on the product monograph.

Duration for Approval of Initials and Renewals: 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests