Pirtobrutinib Demonstrates Notable Progression-Free Survival benefit in First-Line Chronic Lymphocytic leukemia Treatment
Indianapolis, IN – December 7, 2023 – The U.S. Food and Drug Administration (FDA) has granted accelerated approval to pirtobrutinib, marketed as Jaypirca, for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have not received prior treatment. This approval is based on data revealing a clinically meaningful enhancement in progression-free survival (PFS) when pirtobrutinib is used as a first-line therapy.
This marks a significant advancement in CLL treatment, offering a new option for patients initiating therapy. CLL is a type of cancer that affects the blood and bone marrow, impacting approximately 20,000 Americans each year. Current frontline treatments often require intravenous infusions,posing logistical challenges for patients.Jaypirca is an oral medication,potentially improving convenience and quality of life. The approval hinges on continued benefit-risk evaluation in confirmatory trials.
The approval stems from positive results from the BRUIN CLL-001 clinical trial, wich demonstrated pirtobrutinib’s efficacy. The drug is a non-covalent Bruton’s tyrosine kinase (BTK) inhibitor, designed to overcome resistance mechanisms that can develop with other BTK inhibitors.
According to a news release from Eli Lilly and Company, the manufacturer of Jaypirca, the FDA approval was based on a statistically significant and clinically meaningful PFS improvement observed in patients treated with pirtobrutinib compared to those receiving standard care. Further details regarding the trial results are expected to be presented at future medical conferences.
The FDA’s decision provides a new therapeutic avenue for individuals newly diagnosed with CLL or SLL, potentially delaying disease progression and improving outcomes. Patients and healthcare providers can find more information about Jaypirca and its approved uses on the FDA website (https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small-lymphocytic) and the Lilly investor relations website (https://investor.lilly.com/news-releases/news-release-details/us-fda-approves-jaypircatm-pirtobrutinib-first-and-only-non).
