FDA approves Eli Lilly’s Jaypirca for relapsed or refractory CLL/SLL

Eli Lilly and Company has secured approval from the U.S. Food and Drug Administration (FDA) for Jaypirca (pirtobrutinib) tablets, available in 50mg and 100mg strengths, to treat adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This approval applies to patients who have previously received treatment with a covalent Bruton tyrosine kinase (BTK) inhibitor.

The updated approval expands Jaypircas use to earlier lines of therapy, converting its prior accelerated approval in December 2023 for later-stage CLL/SLL into a standard approval. Jaypirca is recognized as the first FDA-approved non-covalent (reversible) BTK inhibitor, designed to selectively inhibit the BTK pathway in patients whose disease has progressed after treatments with covalent BTK inhibitors such as zanubrutinib, acalabrutinib, or ibrutinib.

The FDAs decision is supported by results from the BRUIN CLL-321 Phase III trial, an open-label, randomized study comparing Jaypirca with the investigators choice of bendamustine plus rituximab or idelalisib plus rituximab in patients previously treated with covalent BTK inhibitors. A total of 238 participants were randomized 1:1 to receive either Jaypirca (200mg orally, once daily) or the comparator regimen.

The trials primary endpoint was progression-free survival (PFS), assessed according to the 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria by an independent, blinded review committee. Secondary endpoints included investigator-assessed PFS, event-free survival, duration of response, overall response rate, patient-reported outcomes, time to next therapy, overall survival, as well as safety and tolerability evaluations.

Jacob Van Naarden, executive vice president and president of Lilly Oncology, highlighted that the expanded label allows physicians to prescribe Jaypirca immediately following a covalent BTK inhibitor, where the therapy may have its most significant impact. He emphasized that the robust efficacy and safety demonstrated in this unique post-covalent BTK inhibitor setting now enables earlier intervention for patients with CLL or SLL.

Author: Sophia Brooks