What's Happening?
Eli Lilly is seeking to expand the use of its blood cancer drug Jaypirca into the first-line treatment setting for chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL). The drug, a reversible BTK inhibitor, has shown promising results in the BRUIN CLL-313 trial, significantly improving progression-free survival compared to standard chemoimmunotherapy in previously untreated patients without 17p deletions. Although overall survival data is not yet mature, it trends in favor of Jaypirca. Lilly initially secured FDA approval for Jaypirca in 2023 as a third-line treatment for CLL/SLL and mantle cell lymphoma, targeting patients with resistance mutations to existing BTK inhibitors. The company plans to combine results from the BRUIN CLL-313 and BRUIN CLL-314 trials for a regulatory filing to expand Jaypirca's label later this year.
Why It's Important?
The potential first-line approval of Jaypirca could significantly impact the treatment landscape for CLL/SLL, offering a new option for patients who have not yet received treatment. This move could enhance Lilly's market position against competitors like AbbVie's Imbruvica and AstraZeneca's Calquence, which are already established in the frontline setting. The expansion of Jaypirca's use could lead to increased sales and market share for Lilly, as the drug has already shown strong growth with an 85% increase in prescriptions compared to the previous year. The approval could also provide patients with a more effective treatment option, potentially improving outcomes and quality of life.
What's Next?
Lilly plans to submit a regulatory filing to expand Jaypirca's label later this year, combining data from recent trials. If approved, Jaypirca could become a new standard in first-line treatment for CLL/SLL, challenging existing therapies. The company will likely continue to build clinical evidence to support Jaypirca's use in various treatment settings, including treatment-naïve and BTK inhibitor-exposed patients. Stakeholders, including healthcare providers and patients, will be closely monitoring the approval process and potential changes in treatment protocols.
