The US Food and Drug Administration (FDA) 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 and is administered orally as 50mg or 100mg tablets to achieve a daily 200mg dose.
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The regulatory decision is supported by data from the primary analysis of the global, open-label Phase III BRUIN CLL-313 clinical study.
The trial randomised 282 treatment-naive patients to receive either single-agent pirtobrutinib or a chemoimmunotherapy regimen of bendamustine and rituximab.
Over a median follow-up period of 28 months, pirtobrutinib demonstrated a statistically significant improvement in progression-free survival assessed by an independent review committee, recording a hazard ratio of 0.20.
Median progression-free survival was not reached in the pirtobrutinib cohort compared to 33.5 months in the comparator arm. The overall response rate reached 94% for pirtobrutinib and 81% for the control group.
Lilly Oncology executive vice-president and president Jacob Van Naarden 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.
“This milestone underscores Jaypirca’s versatility in the CLL continuum of care, from the first-line setting for appropriate patients to its valuable role in the relapsed or refractory post-covalent BTK inhibitor setting, reinforcing Jaypirca’s broad applicability as a meaningful treatment option for people with CLL or SLL.”
During the Phase III trial, serious adverse reactions occurred in 28% of patients treated with Jaypirca, with pneumonia observed in 5%. Adverse events resulted in dose reductions for 3.6% of patients and treatment discontinuation for 4.3%.
The National Comprehensive Cancer Network guidelines include Jaypirca as a Category 2A recommendation for untreated CLL/SLL patients without 17p deletions who are older with cardiac comorbidities.
It is also listed as a Category 1 preferred option for patients with relapsed or refractory disease following prior covalent BTK inhibitor therapy.
Both CLL and SLL are slow-growing non-Hodgkin lymphomas that originate in lymphocytes.
Last month, the US FDA approved Lilly’s Onswik (insulin efsitora alfa-gobe), a once-weekly basal insulin injection for adults with type 2 diabetes (T2D).
