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) |
| ICD-10 codes (AIS) | C34.0Malignant neoplasm of carina, C34.1Malignant neoplasm of upper lobe, bronchus or lung, C34.2Malignant neoplasm of middle lobe, bronchus or lung, C34.3Malignant neoplasm of lower lobe, bronchus or lung, C34.8Malignant neoplasm of overlapping sites of bronchus and lung, C34.9Malignant neoplasm of unspecified part of bronchus or lung |
| Alpha-ID codes (AIS) | I111155Carcinoma of the upper lobe bronchus, I116693Non-small cell lung cancer, I24595Carcinoma of the main bronchus, I30015Lung carcinoma of the middle lobe, I30021Lung carcinoma of the lower lobe, I30022Malignant neoplasm of the bronchi and lungs, overlapping several sub-areas |
| Therapeutic area | Oncological diseases Non-small-cell lung carcinoma (NSCLC) |
| Reason for procedure | New therapeutic indication |
| Specialty | Bundling |
| Therapeutic indication of the resolution |
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Rybrevant is indicated in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with advanced NSCLC with activating exon 20 insertion mutations of EGFR. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adults with advanced NSCLC and with activating exon 20 insertion mutations of EGFR; first-line therapy | Cisplatin in combination with a third-generation cytostatic agent (vinorelbine or gemcitabine or docetaxel or paclitaxel or pemetrexed) or – carboplatin in combination with a third-generation cytostatic (vinorelbine or gemcitabine or docetaxel or paclitaxel or pemetrexed) see Annex VI to Section K of the Medicines Directive (AM-RL) or – Carboplatin in combination with nab-paclitaxel |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (PAPILLON) 0 (Data not accepted) |
|---|---|
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Study design
(best subpopulation) |
Data not accepted (Dossier: H2H vs. ACT) |
- 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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