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Jaypirca ® (pirtobrutinib) tablets
50 mg,100 mg
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
Is Jaypirca® (pirtobrutinib) FDA approved?
Jaypirca (pirtobrutinib) is approved by the FDA for use in the United States for the treatment of adult patients with MCL and CLL/SLL.
Pirtobrutinib Approval in the United States
Mantle Cell Lymphoma
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
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Pirtobrutinib was approved by United States FDA for its use in the United States on December 3, 2025 for the treatment of patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
Pirtobrutinb is indicated for the treatment of adult patients with relapsed or refractory CLL or SLL who have previously been treated with a covalent BTK inhibitor.1
Prior FDA Approvals
Pirtobrutinib was previously approved under accelerated approval by United States FDA for its use in the United States on December 1, 2023 for the treatment of patients with CLL or SLL based on the results of the phase 1/2 BRUIN study.
Enclosed Prescribing Information
Enclosed Patient Information
Reference
1Jaypirca [package insert]. Indianapolis, IN: Eli Lilly and Company; 2025.
Date of Last Review: December 09, 2024