Rybrevant
Authorised
This medicine is authorised for use in the European Union
amivantamab
MedicineHumanAuthorised
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 known as ‘activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations’.
The medicine is used in combination with platinum-based cancer medicines in patients who have not been treated before. It is also given on its own when previous treatment with platinum-based medicines has not worked well enough.
Rybrevant contains the active substance amivantamab.
The medicine can only be obtained with a prescription. Treatment with Rybrevant should be started and supervised by a doctor who is experienced in using cancer medicines and given in a setting where any infusion-related side effects can be managed.
Rybrevant is given as an infusion (drip) into a vein. The first week’s dose is split over two successive days, and the medicine is then given once weekly for the next three weeks. After that, the medicine is given once every three weeks when used in combination with platinum-based cancer medicines, once every two weeks if used on its own. Treatment is continued until the disease gets worse or side effects become too severe. Treatment should be stopped temporarily or permanently, and subsequent doses may be reduced, if the patient experiences certain side effects.
Patients should be given antihistamines (allergy medicines), antipyretics (fever-reducing medicines), and corticosteroids before the first treatment to reduce infusion-related reactions. In the following treatment sessions, patients should be given antihistamines and antipyretics.
For more information about using Rybrevant, see the package leaflet or contact your doctor or pharmacist
In NSCLC cells with activating EGFR exon 20 insertion mutations, the EGFR protein is overactive, causing uncontrolled growth of cancer cells.
The active substance in Rybrevant, amivantamab, is a monoclonal antibody (a type of protein) designed to recognise and attach to two receptors (targets) on the surface of the NSCLC cells simultaneously. One part of the antibody attaches to EGFR with activating EGFR Exon 20 insertion mutations. The other part attaches to MET, a receptor important for cancer growth and metastasis (cancer that spreads to another part of the body). By attaching to the two receptors, amivantamab blocks them from receiving the messages the cancer cells need for growing and spreading. The attached antibody also attracts and activates immune cells to kill the targeted cancer cells.
The benefits of Rybrevant were investigated in two main studies in patients with NSCLC with activating EGFR exon 20 insertion mutations.
In one main study, Rybrevant was effective at reducing the size of the cancer in patients who had previously been treated with platinum-based cancer medicines. Rybrevant was not compared with any other treatment or placebo (a dummy treatment). The response to treatment (shrinkage in size of the cancer) was assessed using body imaging. In around 37% (42 out of 114) of the patients, the cancer shrank after treatment with Rybrevant. On average, responses lasted for just over 12 months.
The second main study, involving over 300 patients, compared the effect of Rybrevant in combination with platinum-based medicines with that of platinum-based medicines alone in patients who had not been treated before. On average, patients given Rybrevant plus platinum-based medicines lived 11.4 months without their disease getting worse, compared with 6.7 months for patients given only platinum-based medicines.
For the full list of side effects and restrictions with Rybrevant, see the package leaflet.
When used on its own, the most common side effects with Rybrevant (which may affect more than 1 in 5 people) include rash, infusion-related reactions, nail toxicity (nail abnormalities with pain or discomfort), hypoalbuminaemia (low blood levels of the protein albumin), oedema (fluid retention), tiredness, stomatitis (inflammation of the lining of the mouth), nausea (feeling sick), and constipation. The most common serious side effects (which may affect more than 1 in 100 people) are interstitial lung disease (disorders causing scarring in the lungs), infusion-related reactions and rash.
When used in combination with platinum-based medicines, the most common side effects with Rybrevant (which may affect more than 1 in 5 people) include rash, nail toxicity, stomatitis, infusion-related reactions, hypoalbuminaemia, oedema, constipation, nausea, decreased appetite, tiredness, an increase in the level of liver enzymes in the blood, diarrhoea, vomiting and hypokalaemia (low blood levels of potassium). The most common serious side effects (which may affect more than 1 in 50 people) are rash, interstitial lung disease, hypokalaemia and vomiting.
Patients with NSCLC with EGFR exon 20 insertion mutations have few available treatment options if their cancer gets worse or does not respond to platinum-based therapy. Studies showed that Rybrevant can provide clinically significant benefits in a group of patients who have limited treatment options. Its side effects were considered manageable with appropriate measures, such as changing the dose or, for infusion-related reactions, modifying the infusion and treating the symptoms.
The European Medicines Agency, therefore, decided that Rybrevant’s benefits are greater than its risks and it can be authorised for use in the EU.
Rybrevant was originally given ‘conditional authorisation’. The authorisation has now been switched to a standard authorisation as the company has provided additional data requested by the Agency.
Since Rybrevant has been given conditional authorisation, the company that markets Rybrevant will provide additional results from an ongoing study in patients with advanced or metastatic NSCLC with activating EGFR Exon 20 insertion mutations. The study will compare the effectiveness of adding Rybrevant to platinum-based chemotherapy versus platinum-based therapy alone for initial treatment.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rybrevant have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Rybrevant are continuously monitored. Suspected side effects reported with Rybrevant are carefully evaluated and any necessary action taken to protect patients.
Rybrevant received a conditional marketing authorisation valid throughout the EU on 09 December 2021. The conditional marketing authorisation was switched to a standard marketing authorisation on 27 June 2024.
Product information
Latest procedure affecting product information: II/0010
27/06/2024
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).
Product details
- Name of medicine
- Rybrevant
- 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
- L01FX06
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Rybrevant is indicated:
- in combination with carboplatin and pemetrexed for the first line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with activating EGFR Exon 20 insertion mutations.
- as monotherapy for treatment of adult patients with advanced NSCLC with activating EGFR Exon 20 insertion mutations, after failure of platinum based therapy.
News on Rybrevant
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