Eli Lilly’s Jaypirca (pirtobrutinib) has received an expanded approval from the U.S. Food and Drug Administration (FDA) for certain adults with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
The approval covers patients who have no known deletion of chromosome 17p (del(17p)), allowing Jaypirca to be used as a first-line treatment in eligible patients. The decision expands the use of Jaypirca beyond its previous role in patients who had already received other treatments.
Jaypirca is a non-covalent Bruton tyrosine kinase (BTK) inhibitor and is currently the only FDA-approved treatment in this class. Unlike covalent BTK inhibitors, it binds to BTK through a reversible mechanism and is designed to block the BTK pathway, which plays an important role in B-cell cancers.
The FDA’s latest decision was supported by results from the Phase 3 BRUIN CLL-313 trial. The study compared Jaypirca with bendamustine plus rituximab in adults with previously untreated CLL or SLL who did not have a known 17p deletion.
After a median follow-up of 28 months, patients receiving Jaypirca had a significantly longer period without disease progression. The risk of disease progression or death was reduced by about 80% compared with bendamustine plus rituximab. Median progression-free survival had not yet been reached for patients receiving Jaypirca, compared with 33.5 months for the chemotherapy combination.
Jaypirca also produced an overall response rate of 94%, compared with 81% for bendamustine plus rituximab. Complete responses were reported in 13% of patients in the Jaypirca group, while 81% achieved a partial response.
The safety results were generally consistent with the known safety profile of Jaypirca. Serious adverse reactions occurred in 28% of patients in the trial, while 4.3% permanently stopped treatment because of adverse reactions. Pneumonia was among the more common serious adverse reactions. The drug’s prescribing information includes warnings related to infections, bleeding, low blood cell counts, heart rhythm problems, liver toxicity and other risks.
CLL is a blood cancer that affects B cells and is one of the most common types of leukemia in adults. SLL is closely related and mainly affects lymph nodes.
The new approval could expand the number of patients who can receive Jaypirca earlier in their treatment journey. Lilly said the decision strengthens the drug’s role across different stages of CLL and SLL, from first-line treatment to use in patients whose disease has returned or stopped responding after earlier BTK inhibitor treatment.
Jaypirca is also recommended by the National Comprehensive Cancer Network for certain patients with CLL/SLL. Lilly continues to study pirtobrutinib in multiple Phase 3 trials to evaluate its potential across different treatment settings.