December 03, 2025
1 min read
The FDA has approved pirtobrutinib for certain adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
The new indication applies to adults who previously have been treated with a covalent Bruton tyrosine kinase (BTK) inhibitor, expanding on the 2023 accelerated approval for pirtobrutinib (Jaypirca, Eli Lilly and Co.) for patients who had received at least two prior lines of therapy, including both a BTK inhibitor and a BCL-2 inhibitor.
The agency based its decision on data from the randomized, open-label BRUIN-CLL-321 trial, which included 238 patients previously treated for CLL or small lymphocytic lymphoma with a covalent BTK inhibitor.
Researchers randomly assigned patients 1:1 to receive either pirtobrutinib or investigator’s choice regimen of rituximab (Rituxan; Genentech, Biogen) plus idelalisib (Zydelig, Gilead Sciences) or bendamustine. Patients in the control group were permitted to cross over to the pirtobrutinib monotherapy group following confirmed disease progression in their investigator’s choice regimen.
Patients who received pirtobrutinib monotherapy exhibited improved PFS (HR = 0.58; 95% CI, 0.38-0.89) compared with the investigator’s choice group.
Fifty of 119 patients (42%) in the investigator’s choice group crossed over to receive pirtobrutinib monotherapy during the study. In an updated analysis with a median follow-up of 19.8 months, the HR for OS was 1.09 (95% CI, 0.68-1.75).
The prescribing information for pirtobrutinib includes warnings and precautions for infections, hemorrhage, cytopenias, cardiac arrythmias, secondary primary malignancies, hepatotoxicity and embryo-fetal toxicity.
The recommended dose for pirtobrutinib is 200 mg orally once daily, until disease progression or unacceptable toxicity.
Ask a clinical question and tap into Healio AI’s knowledge base.
- PubMed, enrolling/recruiting trials, guidelines
- Clinical Guidance, Healio CME, FDA news
- Healio’s exclusive daily news coverage of clinical data
