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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 relapsed or refractory MCL after at least two lines of systemic therapy, including a BTK inhibitor.
Pirtobrutinib Approval in the United States
Pirtobrutinib was approved by United States Food and Drug Administration (FDA) for its use in the United States on January 27, 2023.
Mantle Cell Lymphoma
Pirtobrutinib is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (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
Pirtobrutinib is not approved by the United States FDA for the treatment of patients with chronic lymphocytic leukemia (CLL).
Eli Lilly and Company (Lilly) initiated a submission to the US FDA for pirtobrutinib in 2023, seeking accelerated approval for its use in treating CLL after treatment with a BTK inhibitor and B-cell lymphoma-2 (BCL2) inhibitor. Regulatory action is anticipated in late 2023.2 Lilly is actively working with regulatory agencies and cannot speculate on the exact timing of any approval.
Enclosed Prescribing Information
Enclosed Patient Information
1Jaypirca [package insert]. Indianapolis, IN: Eli Lilly and Company; 2023.
2Q2 2023 Earnings Call. Eli Lilly and Company August 8, 2023 Investor Call Slide Deck. Accessed August 8, 2023. https://investor.lilly.com/static-files/66ea0c52-8756-413f-b898-f69c78b191ec
Date of Last Review: August 08, 2023