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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.
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
Enclosed Prescribing Information
Enclosed Patient Information
Reference
1Jaypirca [package insert]. Indianapolis, IN: Eli Lilly and Company; 2023.
Date of Last Review: January 11, 2023