Eli Lilly’s non-covalent Bruton’s tyrosine kinase (BTK) inhibitor Jaypirca (pirtobrutinib) has been granted accelerated approval by the US Food and Drug Administration (FDA) to treat a subset of patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma (CLL/SLL).
The regulator’s decision, which marks its second approval of the drug this year, specifically applies to adults who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.
CLL is one of the most common types of leukaemia in adults, with around 18,740 new cases of the disease diagnosed in the US this year.
CLL and SLL are essentially the same diseases that are treated in the same way but are named depending on the location of the patients’ cancer cells. In CLL, the cancer cells are present in the blood and bone marrow, while in SLL, they appear in the lymph nodes.
“Once patients with CLL or SLL have progressed on covalent BTK inhibitor and BCL-2 inhibitor therapies, treatments are limited and outcomes can be poor,” explained William Wierda, professor, medical director and CLL section head for the Department of Leukemia at the University of Texas MD Anderson Cancer Center.
Lilly’s Jaypirca, which utilises a novel binding mechanism, can extend the benefit of targeting the BTK pathway in CLL/SLL patients previously treated with these therapies, the company said.
The FDA’s approval of the drug was supported by results from a subset of patients in the phase 1/2 BRUIN trial, in which adult patients with CLL/SLL who have received at least two lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor, achieved an overall response rate of 72%.
Jacob Van Naarden, chief executive officer of Loxo@Lilly, said: “This FDA approval – the second for Jaypirca in 2023 – underscores the impactful clinical benefit of continuing to leverage the BTK pathway with Jaypirca for patients with CLL or SLL as seen in the BRUIN trial.”
Jaypirca received its first FDA accelerated approval in January to treat adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor.
“These first two indications for Jaypirca represent the beginning of the eventual impact that we hope Jaypirca can have for patients, and we look forward to seeing the results of the comprehensive phase 3 development programme across CLL, SLL and MCL,” Van Naarden added.