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?
Rybrevant is used to treat certain types of non-small cell lung cancer (NSCLC) in adults. It is given by IV infusion every 1 to 3 weeks, depending on the type of NSCLC being treated.
Rybrevant (amivantamab) is a dual-targeted treatment that binds to both EGFR and MET receptors on cancer cells, blocking their activation by growth factors. It is often used with other cancer treatments.
Rybrevant gained FDA approval on May 21, 2021. There is no generic or biosimilar.
FDA approvals and indications
Rybrevant is approved:
- In combination with lazertinib as a first-line treatment in adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test
- In combination with carboplatin and pemetrexed for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor
- In combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test
- as a single agent to treat adults with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
It is not known if Rybrevant is safe and effective in children.
Mechanism
Rybrevant works primarily by targeting and inhibiting the epidermal growth factor receptor (EGFR) and the mesenchymal-epithelial transition (MET) receptor in cancer cells. It's a bispecific antibody that works through several mechanisms:
- Dual targeting: It binds to both EGFR and MET receptors on cancer cells, blocking their activation by growth factors
- Receptor degradation: Rybrevant causes the internalization and degradation of these receptors, reducing their numbers on cell surfaces
- Antibody-dependent cellular cytotoxicity (ADCC): It activates immune cells to attack and kill the cancer cells it binds to
- Specific EGFR mutations: Rybrevant is particularly effective against non-small cell lung cancers with EGFR exon 20 insertion mutations, which are typically resistant to standard EGFR tyrosine kinase inhibitors.
Rybrevant belongs to the drug class called bispecific EGF receptor-directed and MET receptor-directed antibodies.
Side effects
The most common side effects of Rybrevant when given in combination with lazertinib are:
- rash
- Infected skin around the nail
- muscle and joint pain
- sores in the mouth
- swelling of the hands, ankles, feet, face, or all of your body
- unusual feeling in the skin (such as tingling or a crawling feeling)
- feeling very tired
- diarrhea
- constipation
- COVID-19
- dry skin
- bleeding
- decreased appetite
- itchy skin
- nausea
- changes in certain blood tests.
The most common side effects of Rybrevant when given in combination with carboplatin and pemetrexed are:
- rash
- Infected skin around the nail
- feeling very tired
- nausea
- sores in the mouth
- constipation
- swelling of the hands, ankles, feet, face, or all of your body
- decreased appetite
- muscle and joint pain
- vomiting
- COVID-19
- changes in certain blood tests.
The most common side effects of Rybrevant when given 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.
Your healthcare provider may temporarily stop, decrease your dose, or completely stop your treatment with Rybrevant if you have serious side effects. These are not all of the possible side effects of this medicine.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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 a medicine(s) 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.
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Before taking 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 doctor if you become pregnant or think you may be pregnant.
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. Your healthcare provider will decide how frequently and for how long you will receive treatment.
- Rybrevant is usually given weekly for the first few doses, then less frequently thereafter.
- Pre-medication such as an antihistamine, an antipyretic, and sometimes a glucocorticoid are usually given before each dose of Rybrevant to help reduce the risk of infusion-related reactions.
- 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.
You may need frequent vision exams.
This medicine may cause rash, itching, and dry skin. Use only alcohol-free cream or lotion to treat dry skin.
Dosing information
The dosage is based on body weight and other treatments used.
Usual Rybrevant adult dose 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
Usual Rybrevant adult dose 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
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 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 reading
How 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 reading
References
More about Rybrevant (amivantamab)
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- During pregnancy
- FDA approval history
- Drug class: miscellaneous bispecific antibodies
- Breastfeeding
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Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.