FDA Approves Pirtobrutinib for Untreated CLL/SLL

The FDA approved pirtobrutinib as a first-line monotherapy for adult patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma without 17p deletion, based on positive results from the BRUIN CLL-313 phase 3 trial showing significantly improved progression-free survival versus standard chemoimmunotherapy. The approval introduces a non-covalent BTK inhibitor option with a distinct safety profile and regulatory warnings requiring monitoring of infections, cytopenias, and liver function.

This Wire brief sits within Fusion42's coverage of Biotech, and 9 sources have reported it between 2 Oct 2026 and 6 Oct 2026.