The FDA has expanded Jaypirca's indication to include first‑line treatment for adults with untreated CLL or SLL who lack a 17p deletion, based on the Phase III BRUIN CLL‑313 trial. The study randomised 282 treatment‑naive patients and after a median 28 months of follow‑up showed a strong PFS benefit (HR 0.20) with median PFS not reached for pirtobrutinib versus 33.5 months for bendamustine plus rituximab. Overall response rates were 94% versus 81%, and serious adverse reactions occurred in 28% of patients.
FDA Expands Approval of Lilly’s Jaypirca as First‑Line Treatment for CLL/SLL Without 17p Deletion
Both CLL and SLL are slow-growing non-Hodgkin lymphomas that originate in lymphocytes. Credit: Saiful52/Shutterstock.com.
The US Food and Drug Administration has approved an expanded indication for Eli Lilly and Company's Jaypirca (pirtobrutinib) as a first‑line treatment for adults with previously untreated chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) who do not have a 17p deletion.
Jaypirca is a non‑covalent Bruton tyrosine kinase (BTK) inhibitor administered orally as 50 mg or 100 mg tablets to achieve a total daily dose of 200 mg.
The approval is based on the primary analysis of the global, open‑label Phase III BRUIN CLL‑313 trial. In this study, 282 treatment‑naive patients were randomised to receive either single‑agent pirtobrutinib or a chemoimmunotherapy regimen of bendamustine plus rituximab.
Key Efficacy Results
After a median follow‑up of 28 months, pirtobrutinib produced a statistically significant improvement in progression‑free survival (PFS) as assessed by an independent review committee, with a hazard ratio (HR) of 0.20. Median PFS was not reached in the pirtobrutinib arm versus 33.5 months in the bendamustine‑plus‑rituximab arm. The overall response rate (ORR) was 94% with pirtobrutinib compared with 81% in the comparator group.
Safety Profile
In the Phase III trial, serious adverse reactions occurred in 28% of patients receiving Jaypirca; pneumonia was reported in 5% of patients. Adverse events led to dose reductions in 3.6% of patients and treatment discontinuation in 4.3%.
Jacob Van Naarden, Lilly Oncology Executive Vice‑President and President, said: "This additional approval for Jaypirca, based on BRUIN CLL‑313, marks a significant step forward, expanding its potential to reach more patients who may benefit — this time as an initial treatment for certain previously untreated patients with CLL or SLL."
He added that the approval underscores Jaypirca's versatility across the CLL treatment continuum, from the first‑line setting through to relapsed or refractory disease after covalent BTK inhibitors.
Guideline Positioning
The National Comprehensive Cancer Network (NCCN) includes Jaypirca as a Category 2A recommendation for untreated CLL/SLL patients without 17p deletions who are older and have cardiac comorbidities, and lists it as a Category 1 preferred option for patients with relapsed or refractory disease following prior covalent BTK inhibitor therapy.
About CLL and SLL: Both conditions are slow‑growing non‑Hodgkin lymphomas that originate from lymphocytes.
Separately, last month the US FDA approved Lilly's Onswik (insulin efsitora alfa‑gobe), a once‑weekly basal insulin for adults with type 2 diabetes.
Source: Pharmaceutical Technology (GlobalData).
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