Medicinal products may only be distributed in Switzerland if they are authorised by Swissmedic. The Swiss Agency for Therapeutic Products, is involved in the entire life cycle of a medicinal products because of its mandated areas of responsibility in the sectors of licensing and the authorisation and monitoring of medicinal products.
Summary report on authorisation dated 22 April 2025
Rybrevant® (active substance: amivantamab)
Indication extension in Switzerland: 12 November 2024
Concentrate for solution for infusion for the second-line treatment of adults with locally advanced or metastatic non-small-cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations
About the medicinal product
Rybrevant is a cancer treatment containing the active substance amivantamab.
Swissmedic temporarily approved Rybrevant on 20 January 2022 for the treatment of NSCLC with activating EGFR exon 20 insertion mutations. In the meantime, the associated conditions of authorisation have been fulfilled and the temporary authorisation has been lifted.
Under this indication extension, Rybrevant can now be used in combination with carboplatin and pemetrexed to treat adults with non-small-cell lung cancer (NSCLC) whose cancer is locally advanced or has spread to other parts of their body (metastatic) and whose lung cancer has progressed following treatment with osimertinib.
The medicinal product Rybrevant in combination with carboplatin and pemetrexed is suitable for treating patients in whom a specific change (mutation) is detectable in the gene for the epidermal growth factor receptor[1] (EGFR). These gene changes are called exon 19 deletion or exon 21 L858R substitution mutations of the EGFR genes.
[1] A receptor is a protein or a protein complex located on the surface of, or inside, cells. When a specific substance binds to a receptor, a reaction is triggered in the cell.
Mode of action
The active substance of Rybrevant is amivantamab. Amivantamab is a special antibody that binds specifically to two receptors (targets) on the surface of cancer cells. These receptors, known as EGFR and MET, are often changed in non-small-cell lung cancer. By blocking the signals from these receptors, amivantamab can stop the growth and replication of the cancer cells. In addition, the active substance helps the immune system identify and combat the cancer cells. This slows or stops the growth of the tumours.
Use
Rybrevant is a prescription-only medicine authorised as a concentrate for solution for infusion at the dosage strength of 350 mg / 7 ml. It is administered intravenously (into the veins). Rybrevant is used in combination with carboplatin and pemetrexed.
A precondition for the use of Rybrevant is the detection of a specific EGFR exon 20 deletion or substitution mutation.
The recommended dose for the new indication depends on the patient's weight, i.e. 1,400 mg up to 80 kg and 1,750 mg above 80 kg body weight. Patients receive one dose a week in weeks 1 to 4. After that, Rybrevant is administered every three weeks, the dose increasing to 1,750 mg up to 80 kg and 2,100 mg above 80kg body weight from week 7. Treatment then continues until the disease progresses or the patient experiences intolerable side effects.
Rybrevant is administered by a healthcare professional.
Efficacy
The efficacy of Rybrevant was investigated in the MARIPOSA-2 study.
The study compared a combination of the active substance in Rybrevant (amivantamab), carboplatin and pemetrexed (ACP) with a combination of carboplatin and pemetrexed (CP) on their own. Carboplatin and pemetrexed are chemotherapy medications used as standard treatments for NSCLC.
A total of 394 patients took part who had advanced or metastatic non-small-cell lung cancer (NSCLC) with EGFR exon 19 or exon 21 L858R substitution mutations and whose disease had progressed following previous monotherapy with osimertinib.
This study showed a significant improvement in progression-free survival (PFS)[2] in the ACP group compared with the CP group. Median[3] PFS was 6.3 months in the ACP group compared with 4.2 months in the CP group.
The data currently available from the ongoing study do not show any significant improvement in overall survival. Overall survival refers to the period between the start of treatment and the death of the patient.
[2] PFS (progression-free survival): Period between the start of a treatment or a clinical trial and the onset of disease progression or the death of the patient.
[3] Median: The value that lies exactly in the middle of a distribution of data is called the median or central value. Half of the data values are always less than the median, the other half are always greater.
Precautions, undesirable effects & risks
Rybrevant must not be used in those who are hypersensitive to the active substance amivantamab.
The most common undesirable effects include infusion-related reactions, rash and nail disorders.
Other side effects include nausea, fatigue, reduced appetite and venous thromboembolic events (VTE)[4].
There is also a risk of interstitial lung disease (ILD)[5] and skin reactions such as toxic epidermal necrolysis (TEN)[6].
All precautions, risks, and other possible undesirable effects are listed in the Information for healthcare professionals.
[4] Venous thromboembolic events (VTE) can be life-threatening and are associated with blood clots that form in the veins and may cause pulmonary embolism or deep vein thrombosis
[5] Interstitial lung disease (ILD) is a group of lung diseases characterised by inflammation and scarring of the lung tissue that can cause respiratory symptoms and restricted oxygen absorption.
[6] Toxic epidermal necrolysis (TEN) is a rare but serious skin disease involving extensive blistering and peeling of the top layer of skin.
Why the medicinal product has been authorised
Patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations that progresses after osimertinib therapy currently have limited medication-based treatment options.
The study described above shows that Rybrevant in combination with carboplatin and pemetrexed offers significantly improved progression-free survival.
Taking all the risks and precautions into account, and based on the available data, the benefits of Rybrevant outweigh the risks. Swissmedic has therefore authorised the indication extension for Rybrevant in Switzerland for the treatment of advanced or metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution.
Further information on the medicinal product
Information for healthcare professionals:
Healthcare professionals can answer any further questions.
Printable version
Rybrevant® (active substance: amivantamab) (PDF, 736 kB, 22.04.2025)Extension of therapeutic indication (01)
The date of revision of this text corresponds to that of the SwissPAR. New information concerning the authorised medicinal product in question will not be incorporated into the Summary report on authorisation.
Swissmedic monitors medicinal products authorised in Switzerland. Swissmedic initiates the necessary action in the event of newly discovered adverse drug reactions or other safety-relevant signals. New findings that could impair the quality, efficacy, or safety of this medicinal product are recorded and published by Swissmedic. If necessary, the medicinal product information is adapted.