Pirtobrutinib was first approved by United States Food and Drug Administration (FDA) for its use in the United States on January 27, 2023 for the treatment of patients with mantle cell lymphoma (MCL).

Pirtobrutinib is indicated for the treatment of adult patients with relapsed or refractory MCL after at least two lines of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor.1

This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.1

Pirtobrutinib was approved by United States Food and Drug Administration (FDA) for its use in the United States on December 1, 2023 for the treatment of patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). 

Pirtobrutinib is indicated for the treatment of adult patients with CLL/SLL who have received at least two prior lines of therapy, including a BTK inhibitor and a B-cell lymphoma-2 (BCL-2) inhibitor.1

This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.1

The CLL-321 study is a confirmatory phase 3 study.2 The primary results were shared with FDA, and the updated results will also be shared in the future. We cannot provide guidance on regulatory timelines at this time.3