Posted by Michael Wonder on 03 Dec 2025
FDA grants traditional approval to pirtobrutinib for chronic lymphocytic leukaemia and small lymphocytic lymphoma
3 December 2025 - Today, the FDA granted traditional approval to pirtobrutinib (Jaypirca, Eli Lilly and Company) for adults with relapsed or refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor.
In 2023, FDA granted accelerated approval to pirtobrutinib for adults with CLL/SLL who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.
