Eli Lilly and Company — Retsevmo EMA EPAR public assessment report (EMEA/H/C/005375, 2021)
Eli Lilly and Company · 2021 · EMA EPAR public assessment report · company profile →
Report summary
Eli Lilly's Retsevmo (selpercatinib) received a positive CHMP opinion in December 2020 for advanced RET fusion-positive NSCLC and thyroid cancer, and RET-mutant MTC, based on the LIBRETTO-001 study. This selective RET inhibitor demonstrated dose-dependent tumor regression in preclinical models and established 160 mg BID as the recommended dose. The pivotal Phase 1/2 LIBRETTO-001 study showed promising efficacy (ORR, DOR, PFS, OS) and safety in various RET-altered solid tumors, including those with CNS metastases. The report details drug quality, pharmacokinetics, and toxicology, noting reproductive toxicity concerns. Conditional marketing authorization requires ongoing Phase 3 trials (LIBRETTO-431, LIBRETTO-531) to confirm long-term efficacy and safety.
Key findings — cited to the page
| ALT elevations (any grade) | 49.5 % | LIBRETTO-001 · p.109 |
| Grade ≥3 haemorrhagic events | 2.4 % | LIBRETTO-001 · p.110 |
| Patients with Grade 3 or higher TEAEs related to selpercatinib | 32.0 % | LIBRETTO-001 · p.104 |
| Grade 3-4 AST increase | 8.3 % | LIBRETTO-001 · p.106 |
| Grade 3 or 4 ALT elevations | 10.6 % | LIBRETTO-001 · p.109 |
| Grade 3 or 4 AST elevations | 9.0 % | LIBRETTO-001 · p.109 |
| Patients with at least 1 TEAE of any grade | 99.2 % | LIBRETTO-001 · p.104 |
| Patients with Grade 3 or higher TEAEs | 59.7 % | LIBRETTO-001 · p.104 |
| Grade 3-4 hypertension | 19.2 % | LIBRETTO-001 · p.106 |
| Grade 3-4 ALT increase | 9.8 % | LIBRETTO-001 · p.106 |
| AST elevations (any grade) | 55 % | LIBRETTO-001 · p.109 |
| Hypersensitivity (all grades) | 5.2 % | LIBRETTO-001 · p.112 |
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 →