Rybrevant
amivantamab
Table of contents
Overview
Rybrevant is a cancer medicine used to treat adults with advanced non-small cell lung cancer (NSCLC) whose cancer cells have certain genetic changes. These changes are in the gene for a protein that controls cell growth, epidermal growth factor receptor (EGFR), and are known as ‘activating EGFR exon 20 insertion mutations’. The medicine is given when cancer treatment with platinum-based medicines has not worked well enough.
Rybrevant contains the active substance amivantamab.
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Rybrevant : EPAR - Medicine Overview (PDF/110.02 KB)
First published: 01/02/2022
EMA/602814/2021 -
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Rybrevant : EPAR - Risk management plan summary (PDF/140.12 KB)
First published: 01/02/2022
Authorisation details
Product details | |
---|---|
Name |
Rybrevant
|
Agency product number |
EMEA/H/C/005454
|
Active substance |
amivantamab
|
International non-proprietary name (INN) or common name |
amivantamab
|
Therapeutic area (MeSH) |
Carcinoma, Non-Small-Cell Lung
|
Anatomical therapeutic chemical (ATC) code |
L01FX
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Conditional approval |
This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation. |
Publication details | |
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Marketing-authorisation holder |
Janssen-Cilag International N.V.
|
Revision |
3
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Date of issue of marketing authorisation valid throughout the European Union |
09/12/2021
|
Contact address |
Turnhoutseweg 30 |
Product information
20/09/2023 Rybrevant - EMEA/H/C/005454 - IB/0009/G
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Antineoplastic agents
Therapeutic indication
Rybrevant as monotherapy is indicated for treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) Exon 20 insertion mutations, after failure of platinum-based chemotherapy.