FDA Grants Accelerated Approval to Pirtobrutinib for CLL

The US Food and Drug Administration (FDA) has granted accelerated approval for the use of pirtobrutinib in adults with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor and a BCL-2 inhibitor.

This accelerated approval was based on efficacy results from the BRUIN trial, a pen-label, international, single-arm, multicohort trial in which pirtobrutinib was administered orally at 200 mg once daily and continued until disease progression or unacceptable toxicity. 200 mg daily was established as the recommended dose.

The overall response rate (ORR) was 72% (95% CI: 63, 80) and the median duration of response (DOR) was 12.2 months (95% CI: 9.3, 14.7).

The most common adverse events were fatigue, bruising, cough, musculoskeletal pain, COVID-19, diarrhea, pneumonia, abdominal pain, dyspnea, hemorrhage, edema, nausea, pyrexia, and headache.