Rybrevant
Pronunciation: RYE–breh–vant
Generic name: amivantamab-vmjw
Dosage form: injection for intravenous infusion (350 mg/7 mL)
Drug class: Miscellaneous bispecific antibodies
What is Rybrevant? NSCLC Cancer Treatment Overview
Rybrevant is used to treat non-small cell lung cancer (NSCLC) in adults with specific EGFR mutations. This bispecific antibody is used when lung cancer has locally advanced or metastasized. Rybrevant is given by IV infusion every 1 to 3 weeks.
Rybrevant (amivantamab) gained FDA approval on May 21, 2021, and is made by Janssen Biotech (Johnson & Johnson Innovative Medicine). There is no generic or biosimilar.
How Does Rybrevant Work for Lung Cancer?
Rybrevant is a targeted cancer therapy that works differently from traditional chemotherapy. It targets two specific proteins on cancer cells.
Dual-Target Mechanism
- Rybrevant is a bispecific monoclonal antibody that simultaneously targets EGFR (Epidermal Growth Factor Receptor) and MET (mesenchymal-epithelial transition factor) receptors on cancer cells.
- Once bound, it either prevents these proteins from functioning or triggers their degradation.
- Rybrevant also activates immune cell responses by marking cancer cells for destruction via antibody-dependent cellular cytotoxicity (ADCC) and trogocytosis.
- Rybrevant is very effective against NSCLC with specific EGFR mutations, including exon 19 deletions, L858R substitutions, and exon 20 insertions.
Rybrevant FDA Approvals and Indications
First-Line Treatment (Newly Diagnosed)
Locally advanced or metastatic non-small cell lung cancer (NSCLC) with:
- EGFR exon 19 deletions or exon 21 L858R substitution mutations: Combined with lazertinib
- EGFR exon 20 insertion mutations: Combined with carboplatin and pemetrexed.
Second-Line Treatment (Disease Progression)
Locally advanced or metastatic non-small cell lung cancer (NSCLC) with:
- EGFR exon 19 deletions or exon 21 L858R substitution mutations: When NSCLC has progressed on or after treatment with an EGFR tyrosine kinase inhibitor. Used in combination with carboplatin and pemetrexed.
- EGFR exon 20 insertions: When NSCLC has progressed on or after treatment with platinum-based chemotherapy. Used alone.
Note: The safety and effectiveness of Rybrevant in pediatric patients has not been established.
Rybrevant Side Effects and Safety Profile
Common Side Effects (Combination with Lazertinib)
- Skin reactions: Rash, infected nail areas, dry skin, itching
- Systemic effects: Fatigue, muscle/joint pain, swelling (edema)
- Gastrointestinal: Mouth sores, diarrhea, constipation, nausea
- Other: Unusual skin sensations, decreased appetite, bleeding, COVID-19, and changes in certain blood tests.
Common Side Effects (Combination with Carboplatin/Pemetrexed)
- Rash and nail infections
- Severe fatigue
- Nausea and vomiting
- Mouth ulcers
- Body swelling
- Loss of appetite
- Constipation
- Swelling of the hands, ankles, feet, face, or all of your body
- Muscle and joint pain
- COVID-19
- Changes in certain blood tests.
Common Side Effects When Used Alone
- Rash
- Infected skin around the nail
- Muscle and joint pain
- Shortness of breath
- Nausea
- Feeling very tired
- Swelling of the hands, ankles, feet, face, or all of your body
- Sores in the mouth
- Cough
- Constipation
- Vomiting
- Changes in certain blood tests.
Serious side effects and warnings
Rybrevant can cause the following serious side effects:
Infusion-related reactions. Infusion-related reactions are common but can be severe or serious and can include life-threatening (anaphylaxis) allergic reactions. Tell your healthcare provider right away if you get any of the following symptoms during your infusion of Rybrevant:
- shortness of breath, difficulty breathing, or wheezing
- flushing
- chest discomfort
- skin rash, hives, or itching
- swelling of your eyes, lips, or tongue
- nausea or vomiting
- fever
- stomach cramps
- chills
- lightheadedness, dizziness, or fainting
- numbness of the tongue, lips, cheeks, or gums
- headache.
Lung problems. Rybrevant may cause lung problems that may lead to death. Symptoms may be similar to those symptoms from lung cancer. Tell your healthcare provider right away if you get any new or worsening lung symptoms, including shortness of breath, cough, or fever.
Blood clot problems. Blood clots are a serious, but common side effect of Rybrevant, when given together with another drug called lazertinib, may cause blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism) that may lead to death. Your healthcare provider will start you on medicine to prevent blood clots for the first 4 months of treatment. Tell your healthcare provider right away if you have any signs and symptoms of blood clots, including swelling, pain, or tenderness in the leg, sudden unexplained chest pain, or shortness of breath.
Skin problems. Rybrevant can cause a severe rash, including blisters, peeling, skin pain and sores, redness, raised acne-like bumps, itching, and dry skin. You may use alcohol-free (such as isopropanol-free, ethanol-free) moisturizing cream to reduce the risk of skin problems. Tell your healthcare provider right away if you get any skin reactions. Your healthcare provider may treat you with medicines or send you to see a skin specialist (dermatologist) if you get skin reactions during treatment with Rybrevant.
Eye problems. Rybrevant may cause eye problems. Tell your healthcare provider right away if you get symptoms of eye problems, which may include:
- eye pain
- changes in vision
- inflammation of the eyelids
- itchy eyes
- dry eyes
- excessive tearing
- eye redness
- sensitivity to light
- blurred vision.
Your healthcare provider may send you to see an eye specialist (ophthalmologist) if you get new or worsening eye problems during treatment with Rybrevant. You should not use contact lenses until your eye symptoms are checked by a healthcare provider.
Rybrevant may harm an unborn baby.
This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Related/similar drugs
Before receiving this medicine
Before you receive Rybrevant, tell your healthcare provider about all of your medical conditions, including if you:
- have a history of lung or breathing problems
- are pregnant or plan to become pregnant
- are breastfeeding or intend to breastfeed.
Pregnancy
Rybrevant can harm your unborn baby. Females who can become pregnant may need a pregnancy test to make sure they are not pregnant before treatment. Use birth control while using Rybrevant and for at least 3 months after your last dose. Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment with Rybrevant.
Breastfeeding
It is not known if Rybrevant passes into your breast milk. Do not breastfeed during treatment and for 3 months after your last dose of Rybrevant.
How is Rybrevant administered?
Rybrevant will be given to you by your healthcare provider as an intravenous infusion into your vein.
- Rybrevant is usually given weekly initially. The starting dose may be given as a split infusion on Day 1 and Day 2.
- Your healthcare provider will decide how frequently and for how long you will receive treatment.
You may be given pre-medication with an antihistamine, an antipyretic, and sometimes a glucocorticoid before each dose of Rybrevant to help reduce the risk of infusion-related reactions.
Rybrevant is often given in combination with other medicines, such as lazertinib, carboplatin, or pemetrexed.
- If you are receiving lazertinib, you should take your dose of lazertinib by mouth anytime before your infusion with Rybrevant.
Rybrevant is infused slowly to start with to reduce the risk of infusion-related reactions. Subsequent infusions will be quicker if you tolerate Rybrevant well.
If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.
Dosing information
Dose of Rybrevant for NSCLC in combination with lazertinib or as a single agent
Less than 80 kg:
- Weeks 1-5: 1050 mg IV
- Week 7 onwards: 1050 mg IV
Greater than or equal to 80 kg:
- Weeks 1-5: 1400 mg IV
- Week 7 onwards: 1400 mg IV
Dose of Rybrevant for NSCLC in combination with carboplatin and pemetrexed
Less than 80 kg:
- Weeks 1-4: 1400 mg IV
- Week 7 onwards: 1750 mg IV
Greater than or equal to 80 kg:
- Weeks 1-4: 1750 mg IV
- Week 7 onwards: 2100 mg IV
Clinical Trial Results Supporting Rybrevant Efficacy
MARIPOSA Trial Results
- NCT04487080: 858 patients with exon 19 deletions or exon 21 L858R EGFR mutations.
- Rybrevant + Lazertinib vs osimertinib.
- 30% lower disease progression risk versus osimertinib.
- Median progression-free survival: 23.7 vs 16.6 months.
- 25% lower death risk.
MARIPOSA-2 Study Outcomes
- NCT04988295: 394 second-line patients with EGFR mutations.
- Rybrevant + chemotherapy vs chemotherapy.
- 52% reduced disease progression risk vs chemotherapy alone.
- Response rates: 53% vs 29%.
PAPILLON Trial Data
- NCT04538664: 308 patients with EGFR exon 20 insertion mutations.
- Rybrevant + chemotherapy vs chemotherapy.
- 60% reduced disease progression risk vs chemotherapy alone.
- Median progression-free survival: 11.4 months vs 6.7 months.
- Response rates: 67% versus 37%.
CHRYSALIS Study Results
- NCT02609776), 81 patients with exon 20 insertion-mutations.
- 40% overall response rate.
- Median response duration: 11.1 months.
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your next injection.
What should I avoid while taking Rybrevant?
Rybrevant can cause skin reactions. You should limit your time in the sun during and for 2 months after your treatment. Wear protective clothing and use sunscreen during treatment.
What other drugs will affect Rybrevant?
Other drugs may affect Rybrevant, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. No formal drug interaction studies have been conducted with Rybrevant.
Rybrevant Package Insert
Review the Rybrevant Package Insert for more detailed information about this medicine. Discuss any medical questions with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.
Ingredients
Active ingredient: amivantamab-vmjw
Inactive ingredients: EDTA disodium salt dihydrate, L-histidine, L-histidine hydrochloride monohydrate, L-methionine, polysorbate 80, sucrose, and water for injection.
Available as a solution in a single-dose vial for intravenous infusion of 350 mg/7 mL (50 mg/mL).
Manufacturer
Rybrevant (amivantamab-vmjw) is made by Janssen Biotech, a pharmaceutical company owned by Johnson & Johnson.
Rybrevant Biosimilars
Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.
Reference products
These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Rybrevant.
Rybrevant (amivantamab-vmjw) - Janssen Biotech, Inc.
Formulation type | Strength |
---|---|
Single-Dose Vial | 350 mg/7 mL (50 mg/mL) |
Popular FAQ
How do Exkivity and Rybrevant compare for NSCLC?
Exkivity has been withdrawn from the U.S. market. In clinical studies, close to 28% of patients had a partial response (tumor shrinkage) to Exkivity treatment for Exon 20 mutations and the response lasted for about 17.5 months. About 40% of participants had a response to single agent Rybrevant treatment, and the duration of response (DoR) lasted for a median of 11.5 months. Continue reading
How does Rybrevant work?
Rybrevant is a targeted medicine that works at the epidermal growth factor receptor (EGFR) gene mutation and MET receptor found in certain types of non-small cell lung cancer (NSCLC). EGFR and MET are proteins that help cells to grow. Targeting these proteins helps to slow down or stop cancer growth.
Continue readingHow is Rybrevant administered?
Rybrevant is given as an intravenous (IV) infusion into your vein. Your healthcare provider will administer this medication to you and determine your dose. It may be given alone, in combination with chemotherapy (carboplatin and pemetrexed), or with a kinase inhibitor called Lazcluze (lazertinib) for the treatment of EGFR mutated non-small cell lung cancer (NSCLC).
Continue readingReferences
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Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.