Would a patient with leukemia be considered in remission while taking Brukinsa (zanubrutinib)?

Remission Status for Leukemia Patients on Brukinsa (Zanubrutinib)

A patient with leukemia would not be considered in remission solely by taking Brukinsa (zanubrutinib). Remission requires specific disease assessment criteria beyond medication administration.

Definition of Remission in Leukemia

Remission in leukemia is defined by specific clinical and laboratory parameters, not by the medication being taken:

For Acute Myeloid Leukemia (AML):

• Morphologic Complete Remission (CR) requires 1:
  • Absolute neutrophil count >1000/mcL
  • Platelets >100,000/mcL
  • No residual evidence of extramedullary disease
  • Patient independent of transfusions
  • No residual leukemic blasts in peripheral blood

For Chronic Lymphocytic Leukemia (CLL):

• Complete Remission requires:
  • Absence of lymphadenopathy, hepatomegaly, and splenomegaly
  • Normal blood counts (no cytopenia)
  • Bone marrow with <30% lymphocytes and no lymphoid nodules

Brukinsa (Zanubrutinib) and Disease Status

Brukinsa (zanubrutinib) is FDA-approved for several B-cell malignancies including CLL/SLL, but its use alone does not define remission 2:

• It is a Bruton tyrosine kinase (BTK) inhibitor that requires continuous administration
• Patients remain on treatment until disease progression or unacceptable toxicity
• The medication controls disease but typically does not eliminate it completely

Assessment of Remission Status

To determine if a patient on Brukinsa is in remission:

1. For CLL/SLL patients:

   • Complete clinical examination including lymph node assessment
   • Complete blood count with differential
   • Bone marrow biopsy in patients with complete hematologic remission 1
   • Imaging studies if previously abnormal

2. Response rates with Brukinsa:

   • Overall response rate (ORR) in CLL is approximately 95.9% 3
   • Complete response (CR) rate is only about 18.7% 3
   • Most patients achieve partial response, not complete remission

Clinical Implications

• Patients on Brukinsa typically achieve disease control rather than cure
• Most patients remain on continuous therapy
• The 2-year progression-free survival is approximately 90% 3
• Discontinuation of therapy often leads to disease recurrence

Monitoring Recommendations

For patients on Brukinsa therapy:

• Regular clinical examinations every 3-12 months 1
• Complete blood counts
• Assessment of lymph nodes, liver, and spleen
• Special attention to potential complications:
  • Bleeding events (including major hemorrhage) 4
  • Atrial fibrillation (occurs in approximately 2.8-4% of patients) 3, 5
  • Neutropenia (grade ≥3 in 12.9-15.4% of patients) 3, 5

Bottom Line

A leukemia patient taking Brukinsa is typically considered to have "controlled disease" rather than being "in remission." True remission requires specific disease assessment criteria that go beyond simply taking medication. Most patients on Brukinsa achieve partial responses with ongoing disease control rather than complete remission.