Amivantamab (4) – Rybrevant®
Non-small cell lung cancer, EGFR exon 20 insertion mutation, first-line, combination with carboplatin and pemetrexed
Characteristics
| Start date | 01.02.2025 – Marketing authorisation: 27.06.2024 |
|---|---|
| Resolution | 17.07.2025 |
| Limitation date | 01.07.2026 |
| INN | Amivantamab |
| Brand name | Rybrevant® |
| Pharm. company | Janssen-Cilag GmbH |
| G-BA Procedure ID | D-1161 |
| ATC code | L01FX18 Other monoclonal antibodies and antibody drug conjugates (L01FX) |
| Therapeutic area | Oncological diseases |
| Reason for procedure | New therapeutic indication |
| Specialty | Bundling |
Studies and Results
- Clinical trials
- For the benefit assessment, the pharmaceutical manufacturer submitted the results from the ongoing, open-label, randomised, controlled Phase III PAPILLON trial comparing amivantamab in combination with carboplatin and pemetrexed against carboplatin and pemetrexed alone.
Adults with advanced NSCLC and activating exon 20 insertion mutations in EGFR; first-line treatment
- The additional benefit is not proven.
- Consequently, it is concluded that the data submitted are, on the whole, incomplete, which precludes a proper assessment.
- Overall assessment
- It is therefore concluded that the data submitted are, on the whole, incomplete, which precludes a proper assessment. An additional benefit is therefore not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
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