Calquence

Acalabrutinib

• Brand(s): Calquence
• Dosage Form/Strength: 100 mg tablet
• Effective date: December 3, 2021
  Updated August 10, 2023 – added tablet format

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 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2008 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 at least one prior systemic therapy/regimen.*
   
   AND

3. Acalabrutinib will be used as monotherapy; AND

4. Patient has good performance status.

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

Renewal Criteria:

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

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

• Patients who have experienced disease progression on another Bruton’s tyrosine kinase (BTK) inhibitor (e.g., ibrutinib) for the treatment of CLL.
• Patients with prolymphocytic leukemia.
• Patients with current or history of Richter's syndrome.
• Patients with central nervous system (CNS) lymphoma or leukemia.

Notes:

1. The Ministry will fund only one line of treatment with a BTK inhibitor for CLL.
2. The Ministry will not fund idelalisib following progression on a BTK inhibitor.
3. Patients may switch to acalabrutinib from another BTK inhibitor (e.g., Ibrutinib) 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.).
4. Acalabrutinib 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: 100 mg orally twice daily

Duration for Approval of Initials and Renewals: 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests