Eli Lilly’s Jaypirca approved in US for leukaemia and lymphoma treatment
Betsy Goodfellow | December 4, 2023 | News story | Medical Communications | Eli Lilly, FDA, Jaypirca, Oncology, leukaemia, lymphoma
Eli Lilly has announced that the US Food and Drug Administration (FDA) has approved Jaypirca (pirtobrutinib, 100mg and 50mg tablets) for the treatment of adult patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma (CLL/SLL) who have had at least two prior therapies including a Bruton’s tyrosine kinase (BTK) inhibitor and a BCL-2 inhibitor.
The drug has been approved under the FDA’s Accelerated Approval pathway following overall response rate (ORR) and duration of response (DOR) data from the open-label, single-arm, multicohort, international, phase 1/2 BRUIN trial. The continued approval of the drug is likely to be dependent on verification and description of clinical benefit from further confirmatory trials.
Jacob Van Naarden, chief executive officer of Loxo@Lilly, commented: “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 program across CLL, SLL and MCL.”
Brian Koffman MD, chief medical officer and executive vice president at the CLL Society, added: “The treatment landscape for CLL has been dramatically improved by the introduction of covalent BTK inhibitors and BCL-2 inhibitors. However, most patients will unfortunately relapse eventually. Pirtobrutinib’s approval gives patients a much-needed option and brings forward new possibilities as they continue their treatment journey.”
Betsy Goodfellow
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