Rybrevant

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amivantamab

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 26/09/2022

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
L01XC
Additional monitoringAdditional 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 approvalConditional 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
Marketing-authorisation holder
Janssen-Cilag International N.V.   
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
09/12/2021
Contact address

Turnhoutseweg 30
BE-2340 Beerse
Belgium

Product information

07/07/2022 Rybrevant - EMEA/H/C/005454 - II/0001

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:

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.

Assessment history

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