Unknown MAH — Rybrevant EMA EPAR public assessment report (EMEA/H/C/005454, 2021)
Johnson & Johnson · 2021 · EMA EPAR public assessment report · company profile →
Report summary
The EMA's CHMP granted a positive opinion for conditional marketing authorization of Rybrevant (amivantamab) for advanced NSCLC with EGFR Exon 20 insertion mutations after platinum-based chemotherapy. This addresses a significant unmet medical need, as current therapies are ineffective for this patient population. Amivantamab, a bispecific antibody targeting EGFR and MET, demonstrated significant clinical benefit in the CHRYSALIS study (EDI1001), with an objective response rate of 36.8-43.0% and a median overall survival of 22.8 months. While almost all patients experienced treatment-emergent adverse events (e.g., infusion-related reactions, rash), most were manageable and mild. The quality, manufacturing, and non-clinical aspects of amivantamab were deemed acceptable. A confirmatory Phase 3 study (61186372NSC3001) is required to convert the conditional marketing authorization to a full one, with results due by March 31, 2023. The overall benefit-risk balance is considered positive, with efficacy outweighing the risks.
Key findings — cited to the page
| incidence of infusion modifications due to IRR | 62 % | · p.118 |
| incidence of IRR in All Treated population | 67 % | · p.118 |
| incidence of Grade 3 or higher IRR | 2.0 % | · p.118 |
| incidence of IRR with Day 8 infusion | 1.5 % | · p.118 |
| incidence of IRR with Day 2 infusion | 3.9 % | · p.118 |
| incidence of IRR | 64.4 % | · p.118 |
| incidence of nausea (all grades) | 23 % | · p.126 |
| incidence of fatigue (all grades) | 26 % | · p.126 |
| incidence of serious IRR events | 6 subjects | · p.118 |
| incidence of IRR on Week 1 Day 1 | 66 % | · p.118 |
| incidence of stomatitis (all grades) | 24 % | · p.126 |
| subjects permanently discontinued amivantamab due to IRR | 1.6 % | · p.118 |
Source: Johnson & Johnson ↗ · 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 →