Eli Lilly and Company — Retevmo FDA Review (NDA/BLA 213246, 2026)
Eli Lilly and Company · 2026 · FDA Review (Drugs@FDA) · company profile →
Report summary
Eli Lilly's Retevmo (selpercatinib) received FDA approval for various RET-fusion positive cancers in adults and children, including NSCLC, MTC, and other solid tumors. Efficacy, demonstrated across LIBRETTO trials (e.g., LIBRETTO-001, -431), showed significant improvements in objective response rates, duration of response, and progression-free survival compared to chemotherapy, even in patients with CNS metastases. The LIBRETTO-431 trial, a Phase 3 study in NSCLC, confirmed selpercatinib's superiority. The drug's safety profile, consistent across trials and post-market surveillance, includes common and serious adverse events like hepatotoxicity, ILD/pneumonitis, hypertension, QT prolongation, and hemorrhagic events. Dosage adjustments are recommended for specific conditions. While some adverse events were more frequent with selpercatinib, they were generally manageable, supporting an acceptable risk-benefit profile. Postmarketing requirements and commitments are in place for ongoing clinical trials.
Key findings — cited to the page
| Hypertension (Grade 3) | 20% | · p.17 |
| Hypersensitivity (Grade 3) | 1.9% | · p.18 |
| Increased ALT (all grades) | 55% | · p.17 |
| Hypertension (all grades) | 41% | · p.17 |
| Hemorrhagic events (Grade >=3) | 3.1% | · p.17 |
| Hypersensitivity (all grades) | 6% | · p.18 |
| Increased AST (all grades) | 49% | · p.17 |
| Increased AST (Grade 3 or 4) | 11% | · p.17 |
| Increased ALT (Grade 3 or 4) | 12% | · p.17 |
| Interstitial Lung Disease/Pneumonitis (Grade 3 or 4) | 0.3% | · p.17 |
| Hypertension (Grade 4) | 0.1% | · p.17 |
| Hypothyroidism (all grades) | 13% | · p.18 |
Source: Eli Lilly and Company ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →