Eli Lilly and Company has received approval from the US Food and Drug Administration (FDA) for the expanded use of Jaypirca (pirtobrutinib) tablets, in 100mg and 50mg doses, to treat adults with relapsed or refractory chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).
This applies to patients previously treated with a covalent Bruton tyrosine kinase (BTK) inhibitor.
The approval broadens Jaypirca’s label to cover patients at an earlier stage of treatment and changes the December 2023 accelerated approval for later-line CLL/SLL to a traditional approval status.
Lilly describes Jaypirca as the first FDA-approved non-covalent (reversible) BTK inhibitor, which uses a selective kinase inhibition approach to target the BTK pathway in relapsed or refractory CLL/SLL patients after covalent BTK inhibitor treatment with zanubrutinib, acalabrutinib or ibrutinib.
The FDA approval is based on outcomes from the open-label, randomised BRUIN CLL-321 Phase III trial comparing Jaypirca to investigator's choice of bendamustine and rituximab or idelalisib plus rituximab in patients pre-treated with covalent BTK inhibitors for relapsed and refractory CLL/ SLL.
A total of 238 patients participated in the trial and were randomised in a 1:1 ratio to receive either Jaypirca (200mg orally, once daily) or a regimen chosen by the investigator.
The main outcome measured was progression-free survival (PFS) according to the 2018 International Workshop on Chronic Lymphocytic Leukaemia (iwCLL) criteria, as evaluated by a blinded independent review committee.
Secondary outcomes included PFS as determined by the investigator, event-free survival, duration of response and overall response rate, patient-reported outcomes, time to next treatment and overall survival, and tolerability and safety.
Lilly Oncology executive vice-president and president Jacob Van Naarden stated: “This label expansion allows physicians to use Jaypirca directly after a covalent BTK inhibitor, the setting where we have always believed it has its most unique potential impact for patients.
“With robust efficacy and safety evidence from the only study of its kind in the post-covalent BTK inhibitor treatment setting, we’re proud to now offer this therapy to more patients with CLL or SLL at an earlier stage of their treatment plan.”
