FDA Expands Jaypirca Approval for Previously Untreated CLL/SLL

Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Jaypirca (pirtobrutinib). The non-covalent Bruton tyrosine kinase (BTK) inhibitor can now be used to treat adult patients with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who do not have a known 17p deletion.

This approval allows Jaypirca to be used as a first-line treatment option for eligible patients. The decision is based on results from the BRUIN CLL-313 clinical trial. The study demonstrated that pirtobrutinib significantly delayed disease progression compared to traditional chemoimmunotherapy. At a median follow-up of 28 months, patients treated with pirtobrutinib had not yet reached a median progression-free survival (PFS), while the comparator arm (bendamustine plus rituximab) had a median PFS of 33.5 months.

Jaypirca is the first and only FDA-approved non-covalent BTK inhibitor with a targeted mechanism. Its safety and tolerability profile has remained consistent with previous studies. The drug is considered a valuable option, especially for patients with factors such as older age or comorbidities that may limit treatment choices.

The prescribing information includes warnings and precautions for infections, hemorrhage, cytopenias, cardiac arrhythmias, second primary malignancies, hepatotoxicity, and embryo-fetal toxicity. In the BRUIN CLL-313 trial, adverse reactions led to dose reduction in 3.6% of patients and permanent discontinuation in 4.3%. Serious adverse events occurred in 28% of patients.