Eli Lilly and Company — Jaypirca EMA EPAR public assessment report (EMEA/H/C/005863, 2023)

Report summary

This EMA report details the regulatory assessment of Eli Lilly's Jaypirca (pirtobrutinib) for adult patients with relapsed/refractory mantle cell lymphoma (MCL) previously treated with a BTK inhibitor. The application, initially seeking conditional marketing authorization and accelerated assessment (declined), was supported by the Phase 1/2 LOXO-BTK-18001 study. Jaypirca's pharmaceutical development focused on an amorphous solid dispersion for improved solubility. Non-clinical studies demonstrated its inhibitory activity against BTK and BTK C481S mutants, and its pharmacokinetic profile. Clinical pharmacology detailed its absorption, distribution, and elimination, with no significant exposure-response relationship for efficacy or safety. The pivotal study showed an objective response rate (ORR) of 56.7% and a median duration of response (DoR) of 17.61 months. While acknowledging limitations of the single-arm design, the promising efficacy in a high unmet need population, coupled with a manageable safety profile similar to other BTK inhibitors, led to a positive benefit-risk assessment and conditional marketing authorization. Ongoing pharmacovigilance and a confirmatory Phase 3 study (20019) in BTK inhibitor-naive MCL patients are planned.

Key findings — cited to the page