Zanubrutinib

(Brukinsa®)

Zanubrutinib

Drug updated on 12/11/2024

Dosage FormCapsule (oral; 80 mg)
Drug ClassKinase inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy
  • Indicated for the treatment of adult patients with Waldenstrms macroglobulinemia (WM)
  • Indicated for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen
  • Indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
  • Indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy.

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Summary
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  • This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
  • Zanubrutinib demonstrated a high overall response rate (ORR) of 95.4%, with 100% ORR in treatment-naive (TN) patients and 91.0% in relapsed/refractory (R/R) patients. Among R/R patients, those with one prior line of therapy had an ORR of 97.8%, while those with more than one prior line had an ORR of 90.7%.
  • Progression-free survival (PFS) and overall survival (OS) were longer in TN patients and those with only one prior line of therapy compared to patients with multiple prior lines of therapy.
  • Zanubrutinib monotherapy showed higher ORR and 24-month OS/PFS rates compared to acalabrutinib, demonstrating superior effectiveness in specific subgroups such as treatment-naive patients and those with fewer prior lines of therapy.
  • The most frequent grade ≥3 adverse events (AEs) associated with zanubrutinib were infections (41.7%), neutropenia (34.1%), and thrombocytopenia (9.4%). Atrial fibrillation occurred in 1.9% of patients.
  • Zanubrutinib demonstrated a favorable safety profile compared to other targeted therapies, with fewer incidences of atrial fibrillation and other severe adverse events, making it a safer option for patients with advanced age and comorbidities when used as monotherapy.
  • Zanubrutinib demonstrated higher efficacy in TN patients and those under 65 years old, with better outcomes observed in TN and R/R patients with only one prior line of therapy. Efficacy was consistent across patients regardless of genomic aberrations, and it was particularly safer for older patients with comorbidities when used as monotherapy.