Eli Lilly and Company — Jaypirca EMA EPAR variation assessment report (EMEA/H/C/005863, 2023)
Eli Lilly and Company · 2023 · EMA EPAR variation assessment report · company profile →
Report summary
Eli Lilly sought to extend Jaypirca's (pirtobrutinib) indication for relapsed/refractory CLL patients previously treated with a BTK inhibitor. The application, based on the Phase 3 BRUIN CLL-321 (LOXO-BTK-20020) study, demonstrated superior progression-free survival (median 13.96 vs 8.74 months) and overall response rates (66.4% vs 48.7%) for pirtobrutinib compared to standard therapies. Pharmacokinetic analyses confirmed consistent exposure, with a significant relationship between trough concentration and PFS. The safety profile was consistent with previous findings, with peripheral oedema noted as a new common adverse reaction. An updated Environmental Risk Assessment found no environmental risk. The CHMP recommended approval, concluding a positive benefit-risk balance for the extended indication.
Key findings — cited to the page
| Pirtobrutinib NOEC (Daphnia sp. Reproduction Test) | 1760 µg/L | pirtobrutinib · p.14 |
| Grade 3 or 4 pirtobrutinib-related TEAEs | 28.4 % | Study 20020 Arm A · p.93 |
| Grade 3/4 TEAEs | 47.4 % | · p.94 |
| Pneumonia (Grade 3+) in Arm B | 11.0 % | Study 20020 · p.71 |
| Pneumonia (Grade 3+) in Arm A | 17.2 % | Study 20020 · p.71 |
| Pneumonia (any grade) in Arm B | 11.9 % | Study 20020 · p.71 |
| Grade 3+ TEAE in Arm A | 57.8 % | Study 20020 · p.71 |
| Nausea (any grade) in Arm B | 20.2 % | Study 20020 · p.72 |
| Grade 3 or 4 AEs in Study 20020 Arm A | 55 | Study 20020 · p.71 |
| Grade 3 or 4 AEs in Study 20020 Arm B | 70 | Study 20020 · p.71 |
| Pneumonia (any grade) in Arm A | 22.4 % | Study 20020 · p.71 |
| Nausea (Grade 3+) in Arm B | 0 % | Study 20020 · p.72 |
Source: Eli Lilly and Company ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →