ACALABRUTINIB

Guidelines for Use

Our guideline named ACALABRUTINIB (Calquence) requires the following rules be met for approval:

1. You have ONE of the following diagnoses:
   1. Mantle cell lymphoma (MCL: a type of blood cancer)
   2. Chronic lymphocytic leukemia (CLL: a type of blood cancer)
   3. Small lymphocytic lymphoma (SLL: a type of blood cancer)
2. If you have mantle cell lymphoma (MCL), approval also requires:
   1. You are 18 years of age or older
   2. You have received at least one prior therapy for mantle cell lymphoma
3. If you have chronic lymphocytic leukemia or small lymphocytic lymphoma, approval also requires:
   1. You are 18 years of age or older

Rationale

To promote appropriate utilization of Calquence based on FDA approved indication.

Indications for Use

Calquence is a kinase inhibitor indicated for the treatment of adult patients with:

• Mantle cell lymphoma (MCL) who have received at least one prior therapy
• Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

Dosage and Administration

The recommended dose of Calquence is 100 mg taken orally approximately every twelve hours until disease progression or unacceptable toxicity.

References

Calquence [Prescribing Information]. AstraZeneca Pharmaceuticals: Wilmington, DE; August 2022.