Eli Lilly's Jaypirca Scores FDA Approval for Earlier Use in CLL/SLL Treatment

Eli Lilly has secured a significant victory for its BTK inhibitor Jaypirca (pirtobrutinib), as the U.S. Food and Drug Administration (FDA) grants approval for its use in earlier treatment lines for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). This development marks a crucial expansion of Jaypirca's potential impact in the treatment landscape for these slow-growing forms of non-Hodgkin lymphoma.

Label Expansion and Full Approval

The FDA's decision allows Jaypirca to be used in patients with relapsed or refractory CLL/SLL immediately following treatment with a covalent BTK inhibitor. This expansion comes approximately two years after Jaypirca's initial accelerated approval for later-line treatment. Importantly, the FDA has also converted Jaypirca's accelerated approval to a full, traditional approval, solidifying its place in the CLL/SLL treatment armamentarium.

Jacob Van Naarden, Lilly's oncology head, emphasized the significance of this approval, stating, "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."

Clinical Trial Success

The label expansion and full approval are supported by compelling data from the Bruin CLL-321 study, which compared Jaypirca to established treatment regimens. In this 238-patient trial, Jaypirca demonstrated a 46% reduction in the risk of disease progression or death compared to either Gilead Sciences' Zydelig plus Roche's Rituxan or bendamustine and Rituxan.

Patients treated with Jaypirca experienced a median progression-free survival of 14 months, compared to 8.7 months in the control arm. Dr. Jeff Sharman, principal trial investigator from the Willamette Valley Cancer Institute and Research Center, noted, "When covalent BTK inhibitors are no longer an option due to disease progression or intolerance, pirtobrutinib enables physicians to extend the benefits of targeting the BTK pathway, offering continuity in the CLL or SLL treatment experience."

Jaypirca's Unique Mechanism and Market Position

As a non-covalent BTK inhibitor, Jaypirca distinguishes itself from competitors such as AbbVie and Johnson & Johnson's Imbruvica, AstraZeneca's Calquence, and BeOne Medicines' Brukinsa. Its reversible binding mechanism allows it to be effective in patients who have failed prior treatment with covalent BTK inhibitors, addressing an important unmet need in CLL/SLL treatment.

Jaypirca, which came to Lilly through its $8 billion acquisition of Loxo Oncology in 2019, remains the only marketed non-covalent BTK inhibitor since its debut in 2023. In its first year on the market, Jaypirca generated sales of $337 million, underscoring its rapid adoption and potential for growth in the coming years.