Eli Lilly and Company has received approval from the US Food and Drug Administration (FDA) for its non-covalent (reversible) Bruton’s tyrosine kinase (BTK) inhibitor, Jaypirca (pirtobrutinib, 100mg and 50mg tablets), to treat chronic lymphocytic leukaemia or small lymphocytic lymphoma (CLL/SLL) in adults.
The therapy received approval under the accelerated pathway to treat patients with CLL/SLL who had received at least two prior lines of therapy, including a BCL-2 inhibitor and a BTK inhibitor.
CLL and SLL are slowly progressing non-Hodgkin lymphomas originating from lymphocytes, a type of white blood cell.
Jaypirca is the first and only FDA-approved non-covalent (reversible) BTK inhibitor that can expand the benefit of targeting the BTK pathway in patients with this condition.
The approval is based on the duration of response and overall response rate (ORR) from the single-arm, multicohort, open-label, international Phase I/II BRUIN clinical trial.
It is an ongoing first-in-human study assessing Jaypirca in subjects with haematologic malignancies including mantle cell lymphoma (MCL), SLL and CLL.
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The study includes a Phase I dose-escalation phase, a Phase Ib combination arm, and a Phase II dose-expansion phase.
The primary endpoint of the Phase I study is the maximum tolerated dose/recommended Phase 2 dose.
Its secondary endpoints are safety, pharmacokinetics and preliminary efficacy measured by ORR for monotherapy.
Loxo@Lilly CEO Jacob Van Naarden stated: “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.
“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.”
In November 2023, Lilly collaborated with Prism Biolab for the development and commercialisation of small molecules that modulate targets picked by Lilly.
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