Rybrevant

amivantamab

Table of contents

Opinion

On 14 October 2021, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation1 for the medicinal product Rybrevant, intended for the treatment of non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

The applicant for this medicinal product is Janssen-Cilag International N.V.

Rybrevant will be available as a 350 mg concentrate for solution for infusion. The active substance of Rybrevantis amivantamab, a fully human IgG1-based EGFR MET bispecific antibody that targets tumours with activating EGFR exon 20 insertion mutations (ATC code: L01FX18).

The benefits of Rybrevant are its objective response rate and response duration in NSCLC patients with EGFR exon 20 insertion mutations after failure of platinum‑based therapy. The most common side effects are rash, infusion related reactions, nail toxicity, hypoalbuminemia, oedema, fatigue, stomatitis, nausea, and constipation.

The full indication is:

Rybrevant as monotherapy is indicated for treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) Exon 20 insertion mutations, after failure of platinum-based therapy.

Rybrevant should be prescribed by physicians experienced in the use of cancer therapies.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.


1 A conditional marketing authorisation is granted to a medicinal product that fulfils an unmet medical need when the benefit to public health of immediate availability outweighs the risk inherent in the fact that additional data are still required. The marketing authorisation holder is expected to provide comprehensive clinical data at a later stage.

Key facts

Name
Rybrevant
Agency product number
EMEA/H/C/005454
International non-proprietary name (INN) or common name
  • amivantamab
Active substance
  • amivantamab
Therapeutic area
Carcinoma, Non-Small-Cell Lung
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.

Date opinion adopted
14/10/2021
Company name
Janssen-Cilag International N.V.   
Status
Positive
Application type
Initial authorisation

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