EMA's CHMP issues a positive opinion for the approval of pirtobrutinib in CLL across all lines of therapy

On June 26, 2026, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for the approval of pirtobrutinib, a non-covalent Bruton’s tyrosine kinase (BTK) inhibitor, for the treatment of adult patients with chronic lymphocytic leukemia (CLL) across all lines of therapy, regardless of prior BTK inhibitor exposure.¹

The positive opinion is supported by results from the phase III BRUIN CLL-313 (NCT05023980) study, evaluating pirtobrutinib vs bendamustine + rituximab (BR) in previously untreated patients with CLL/small lymphocytic lymphoma (SLL) without 17p deletions, and results from the phase III BRUIN CLL-314 (NCT05254743) study, evaluating pirtobrutinib vs ibrutinib in patients with CLL/SLL who were either treatment or BTK inhibitor naïve.¹ In BRUIN CLL-313, pirtobrutinib demonstrated an 80.1% reduction in the risk of progressive disease or death compared with BR (hazard ratio [HR], 0.199; 95% confidence interval [CI], 0.107–0.367; p < 0.0001), with a 24-month progression-free survival of 93.4% vs 70.7% .² Grade ≥3 treatment-emergent adverse events (TEAEs) occurred in 40.0% vs 67.4% of patients.² In BRUIN CLL-314, the overall response rates with pirtobrutinib vs ibrutinib were 87.0% vs 78.5% in the intention-to-treat population, 84.0% vs 74.8% in the relapsed/refractory population, and 92.9% vs 85.8% in the treatment-naïve population.³ TEAEs of any grade were reported in a similar proportion of patients treated with pirtobrutinib and ibrutinib (97.0% vs 97.8%), while rates of atrial fibrillation/flutter (2.4% vs 13.5%) and hypertension (10.6% vs 15.1%) were lower with pirtobrutinib.³