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Is pirtobrutinib FDA approved?
Pirtobrutinib is not currently FDA approved for use in the United States.
Pirtobrutinib Submission for Approval
Pirtobrutinib is currently not approved by United States Food and Drug Administration (FDA) for its use in the United States.
Eli Lilly and Company (Lilly) initiated a rolling submission to the US FDA for pirtobrutinib in 2022. On August 4, 2022, Lilly announced that the FDA has accepted pirtobrutinib with a priority review designation. Pirtobrutinib will be reviewed under the accelerated approval path for use in the treatment of patients with mantle cell lymphoma who were previously treated with a Bruton's tyrosine kinase inhibitor.1,2 Lilly is actively working with regulatory agencies and cannot speculate on the exact timing of any approval.
1Lilly reports second-quarter financial results, highlights momentum of new medicines and pipeline advancements. Press release. Eli Lilly and Company; August 4, 2022. Accessed September 2, 2022. https://investor.lilly.com/news-releases/news-release-details/lilly-reports-second-quarter-financial-results-highlights
2Lilly highlights innovation-based growth strategy and pipeline developments; announces 2022 financial guidance at Investment Community Meeting. Press release. Eli Lilly and Company; December 15, 2021. Accessed July 1, 2022. https://www.prnewswire.com/news-releases/lilly-highlights-innovation-based-growth-strategy-and-pipeline-developments-announces-2022-financial-guidance-at-investment-community-meeting-301444845.html
Date of Last Review: September 02, 2022