Rybrevant is a brand-name IV infusion that’s prescribed for a certain type of non-small cell lung cancer (NSCLC). Rybrevant is a biologic that contains the active drug amivantamab-vmjw.
Rybrevant is prescribed to treat a specific form of NSCLC with epidermal growth factor receptors (EGFR-positive NSCLC) in adults. The drug is prescribed for EGFR-positive NSCLC that has specific genetic mutations called exon 20 insertions.
Rybrevant is used when EGFR-positive NSCLC:
- is locally advanced (spread into nearby tissues) or metastatic (spread to other parts of the body, such as the bones), and
- has gotten worse during or after treatment with a platinum-based drug (a type of chemotherapy)
Drug details
You’ll find key information about Rybrevant below.
- Drug class: bispecific antibodies (a type of targeted therapy)
- Drug form: intravenous (IV) infusion given by a healthcare professional at your doctor’s office or an infusion center
- Generic or biosimilar available? no
- Prescription required? yes
- Controlled substance? no
- Year of FDA approval: 2021
- Accelerated approval?
yes *
* The FDA may grant accelerated approval to certain drugs, such as Rybrevant, that are prescribed to treat conditions without many effective treatment options. Accelerated approval is based on results from early clinical trials of the drug. The FDA will make a decision about the full approval of Rybrevant after further clinical trials are completed.
The active ingredient of Rybrevant is amivantamab-vmjw. The drug is a biologic that’s available only as a brand-name medication. It’s not currently available in generic or
A biologic drug is a drug made using living cells, while traditional drugs are made using chemicals. Exact copies of brand-name chemical drugs can be made. These are called generics. Generics are just as safe and effective as the original drug but usually cost less than the brand-name version.
It’s not possible to make exact copies of biologic drugs. Instead, similar versions of brand-name biologic drugs can sometimes be made. These are called biosimilars. As with generics, biosimilars are considered to be just as safe and effective as the original brand-name drug that they’re based on. And similar to generics, they usually cost less than the original brand-name drug.
As with all medications, the cost of Rybrevant can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.
Drug coupons. You can visit Optum Perks* for price estimates of Rybrevant. These estimates are based on the use of Optum Perks coupons. Note: Optum Perks coupons cannot be used with any insurance copays or benefits.
Financial and insurance assistance. If you need financial support to pay for Rybrevant, or if you need help understanding your insurance coverage, help is available.
A program called Janssen CarePath is available for Rybrevant. For more information and to find out whether you’re eligible for support, call 833-RYBREVANT (833-792-7382) or visit the program website.
To learn more about saving money on prescriptions, check out this article.
Biosimilar version. Rybrevant is a biologic drug that’s not available in a
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Rybrevant is prescribed to treat a specific form of non-small cell lung cancer with epidermal growth factor receptors (EGFR-positive NSCLC). For more details about the approved use of Rybrevant, see the “Rybrevant uses” section below.
What happens with EGFR-positive NSCLC?
With EGFR-positive NSCLC, your cancer cells have abnormal EGFRs on their surface. EGFRs are proteins that usually tell your cells to grow and divide. However, they can become abnormal due to genetic mutations (unusual changes in a gene). When this happens, they tell cells to grow and multiply (increase in numbers) in an unmanaged way. This leads to cancer.
EGFR-positive lung cancer may be caused by various genetic mutations. Rybrevant is prescribed for EGFR-positive NSCLC that has specific genetic mutations called exon 20 insertions.
Your doctor will order specific tests to determine whether your lung cancer has these genetic mutations. These tests are approved by the Food and Drug Administration (FDA). And they’ll help your doctor determine if Rybrevant is right for your condition.
What is Rybrevant’s mechanism of action?
Rybrevant is a targeted therapy for a certain form of non-small cell lung cancer with epidermal growth factor receptors (EGFR-positive NSCLC). Rybrevant works by blocking certain proteins that help cancer cells grow and survive. It also helps your immune system detect and fight the cancer cells.
Rybrevant is classified as a bispecific antibody. (It is a type of monoclonal antibody, which is a lab-made protein that acts in the immune system. “Bispecific” means that the drug can bind to two different targets at the same time.) Rybrevant’s mechanism of action (the way it works) is by attaching to EGFR and mesenchymal-epithelial transition (MET) proteins on the surface of cancer cells that have certain genetic mutations (unusual changes in a gene).
When Rybrevant attaches to these proteins, it stops them from sending growth signals to cancer cells. This helps prevent the cancer cells from growing and surviving. It also helps cells in your immune system detect and fight the cancer cells.
If you have additional questions about how Rybrevant works, talk with your doctor or pharmacist.
How long does it take to work?
Rybrevant starts working as soon as you start treatment, but you might not be aware of it working. During your treatment, your doctor will likely order tests from time to time to make sure Rybrevant is working for you.
Rybrevant can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while receiving Rybrevant. These lists do not include all possible side effects.
For more information about the possible side effects of Rybrevant, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.
Keep in mind that the Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Rybrevant, you can do so through MedWatch.
Mild side effects
Mild side effects of Rybrevant can include:
- paronychia (infected skin around one or more of your nails)
- pain in your muscles, bones, or joints
- nausea and vomiting
- shortness of breath
- cough
- edema (swelling caused by fluid buildup)
- stomatitis (inflammation that causes sores inside your mouth or throat)
- fatigue
- constipation
- diarrhea
- dizziness
- headache
- irregular blood test results, such as:
- low level of albumin (the main protein found in blood plasma)
- high levels of liver enzymes (a type of protein)
- low levels of electrolytes, such as sodium and potassium
- high blood sugar
- mild skin reaction*
* For more information about this side effect, see “Side effect details” below.
Most of these side effects may go away within a few days or a couple of weeks. However, if they become more severe or don’t go away, talk with your doctor or pharmacist.
Note: This is a partial list of mild side effects from Rybrevant. To learn about other mild side effects, talk with your doctor or pharmacist. You can also see the drug’s prescribing information, which may be referred to as the Rybrevant PI.
Serious side effects
Serious side effects from Rybrevant aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.
Serious side effects and their symptoms can include:
- Eye problems, such as keratitis (inflammation of the cornea) and uveitis (inflammation of the middle layer of the eye). Symptoms can include:
- eye pain or itching
- eye redness
- dry eyes
- watery eyes
- changes in vision, such as blurry or cloudy vision
- sensitivity to light
- Infusion-related reaction.*
- Lung problems.*
- Severe skin reaction.*
- Severe allergic reaction.*
* For more information about this side effect, see “Side effect details” below.
Side effect details
Here’s some detail on certain side effects this drug may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Rybrevant.
Infusion-related reaction
Rybrevant is given by intravenous (IV) infusion.* So, some people may have an infusion-related reaction with this drug. This is a side effect that happens during or shortly after your infusion.
In clinical trials, infusion-related reactions were common with the first dose of Rybrevant. They were much less common with the second dose and rare with later doses.
Most infusion-related reactions are mild, but on rare occasions, they can be severe. Symptoms of an infusion-related reaction may include:
- flushing
- fever
- chills
- nausea and vomiting
- chest discomfort
- hypotension (low blood pressure), which may make you feel lightheaded or dizzy
- shortness of breath
What you can do
To help prevent infusion-related reactions, your doctor or another healthcare professional will give you certain medications before your Rybrevant infusions. Before your first two infusions, they’ll likely give you:
- an antihistamine, such as diphenhydramine (Benadryl)
- a medication to reduce fever, such as acetaminophen (Tylenol)
- a corticosteroid, such as dexamethasone or methylprednisolone
You may not have a severe reaction to your first two infusions. In this case, your doctor will likely give you only an antihistamine and acetaminophen before your later infusions.
If you have symptoms of an infusion-related reaction, tell your doctor right away. They may give you medication to help ease your symptoms.
Depending on the severity of your symptoms, your doctor may also slow down or pause your infusion. However, if you have a very severe reaction, they’ll likely recommend you stop Rybrevant treatment permanently.
* For more information about how Rybrevant is administered, see the “How Rybrevant is given” section below.
Lung problems
Rybrevant can sometimes cause lung problems. These include:
- interstitial lung disease (inflammation and buildup of scar tissue in your lungs)
- pneumonitis (inflammation in your lungs)
- pneumonia (lung infection)
- pulmonary embolism (blood clot in your lungs)
In clinical trials, lung problems were rare with Rybrevant treatment.
Symptoms of lung problems can be similar to symptoms of lung cancer, which Rybrevant is prescribed to treat.* They may include new or worsening cough, fever, breathlessness, or difficulty breathing.
What you can do
If you have new or worsening lung symptoms, such as those described above, see your doctor right away. They’ll likely stop your Rybrevant infusions while they treat the problem and figure out the cause of your symptoms.
If your doctor determines you have interstitial lung disease or pneumonitis, they’ll stop your Rybrevant treatment permanently.
* For more information about the approved use of Rybrevant, see the “Rybrevant uses” section below.
Skin reaction
Some people may have a skin reaction, such as a skin rash, during Rybrevant treatment. In fact, skin rash was the most common side effect reported with this medication in clinical trials.
Most skin reactions with Rybrevant are mild. However, severe reactions, such as toxic epidermal necrolysis (TEN), are also possible. (TEN is a serious, life threatening skin reaction caused by certain medications.) In clinical trials, severe skin reactions were rare with Rybrevant treatment.
Symptoms of a mild skin reaction may include:
Symptoms of a severe skin reaction may include:
- widespread, severe, or painful skin rash
- skin blistering or peeling
- fever
What you can do
To help prevent skin reactions with Rybrevant treatment, you should try to limit your sun exposure during treatment. You should also do this for 2 months after your last infusion.
If you go out in the sun, be sure to cover your skin with clothing and wear a hat. You should also use sunscreen. If you have dry skin during your treatment, you can also try using an alcohol-free moisturizer.
If you develop a skin rash or other skin reaction during treatment, see your doctor. They may reduce your Rybrevant dose or pause your treatment until your skin reaction gets better. To help ease your skin reaction, your doctor may prescribe medications such as topical corticosteroids (steroid creams or ointments). They may also prescribe antibiotics that you’ll apply to your skin or take orally.
If your skin reaction is severe or doesn’t get better within 2 weeks, your doctor will likely refer you to a dermatologist (a doctor who specializes in skin conditions). They may also recommend stopping your Rybrevant treatment permanently.
ALLERGIC REACTION
As with most drugs, some people can have an allergic reaction after receiving Rybrevant.
Symptoms of a mild allergic reaction can include:
A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:
- swelling under your skin, typically in your eyelids, lips, hands, or feet
- swelling of your tongue, mouth, or throat
- difficulty breathing
Call your doctor right away if you have an allergic reaction to Rybrevant, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.
The Rybrevant dosage your doctor prescribes will depend on several factors. These include your body weight and any side effects you may have. (For more information on side effects with Rybrevant, see the “Rybrevant side effects” section above.)
The following information describes dosages that are commonly prescribed or recommended. However, your doctor will determine the best dosage to fit your needs.
Drug forms and strengths
Rybrevant comes as a solution in a single-dose vial. It’s available in one strength: 350 milligrams per 7 milliliters of solution (mg/mL).
You’ll receive Rybrevant as an intravenous (IV) infusion in your doctor’s office or an infusion center. Your doctor or another healthcare professional will give your infusion.
Dosage for non-small cell lung cancer
The typical recommended dose of Rybrevant is based on your body weight when you start treatment with the drug. Your body weight will be measured in kilograms (kg),* as shown below:
| Body weight | Recommended dose |
| less than 80 kg, or less than about 176 pounds (lb) | 1,050 milligrams (mg) |
| 80 kg or more, or about 176 lb or more | 1,400 mg |
* One kg is about 2.2 lb.
For week 1 of treatment, you’ll receive your recommended dose split between two separate infusions. This is to help prevent an infusion reaction, which is a possible side effect of Rybrevant. You’ll have your first half of the infusion on day 1 and your second half of the infusion on day 2.
For weeks 2–4 of treatment, you’ll typically receive your full recommended dose as one infusion per week. This will be on day 1.
After this, you’ll typically receive your full recommended dose given once every 2 weeks.
What if I miss an appointment for a dose?
If you miss an appointment to have a dose of Rybrevant, call your doctor’s office right away to reschedule.
To help make sure that you don’t miss an infusion appointment, be sure to put your treatment schedule on your calendar. You could also download a reminder app on your phone.
Will I need to receive this drug long term?
Rybrevant is meant to be prescribed as a long-term treatment. If you and your doctor determine that Rybrevant is safe and effective for you, you’ll likely take it for as long as it’s effective for your condition.
Here are answers to some frequently asked questions about Rybrevant.
How do Rybrevant and Tagrisso compare?
Rybrevant and Tagrisso are both targeted therapies for non-small cell lung cancer with epidermal growth factor receptors (EGFR-positive NSCLC). Targeted cancer therapies block specific proteins that help cancer cells grow, multiply, and spread to other parts of your body. However, there are some key differences between these drugs, as shown in the table below:
| Rybrevant* | Tagrisso† | |
| Form | solution that’s given as an intravenous (IV) infusion by a healthcare professional | oral tablet |
| Typical dosage frequency | once every two weeks | once daily |
| Drug type | biologic drug called a bispecific antibody | chemical drug called a tyrosine kinase inhibitor |
| Approved use | EGFR-positive NSCLC with genetic mutations (unusual changes in a gene) called exon 20 insertions | EGFR-positive NSCLC with genetic mutations called exon 19 deletions, exon 21 L858R mutations, or T790M mutations |
* For more details on Rybrevant, see the “How Rybrevant is given” and “Rybrevant uses” sections below. You can also see the “Rybrevant dosage” and “About” sections above.
† To learn more about Tagrisso, see this article.
Your doctor will order various tests to determine whether your cancer is suitable for treatment with Rybrevant or Tagrisso.
Talk with your doctor if you’d like to learn more about how these treatments compare. You can also read more about Tagrisso in this article.
Why do I have to protect my skin from the sun during Rybrevant treatment?
You should try to protect your skin from the sun during Rybrevant treatment. This is to help prevent skin reactions. Skin reactions such as rash, dry skin, and itching are common side effects of Rybrevant. (For more details, see the “Rybrevant side effects” section above.)
Sun exposure can increase your risk of skin reactions and worsen them. If you have skin reactions, they could also make your skin more sensitive to sunlight. So you could more easily get a sunburn.
You should try to limit your sun exposure during Rybrevant treatment and for 2 months after your last infusion. If you go out in the sun, be sure to cover your skin with clothing and wear a hat. You should also use sunscreen.
Is Rybrevant chemotherapy?
No, Rybrevant is not chemotherapy. Instead, Rybrevant is a targeted therapy for non-small cell lung cancer with epidermal growth factor receptors (EGFR-positive NSCLC).*
Chemotherapy is a traditional treatment prescribed to treat many types of cancer. It works by killing all cells that rapidly grow and multiply (increase in numbers) in your body. This includes healthy cells as well as cancer cells. For this reason, chemotherapy often causes side effects, especially low blood cell counts and hair loss.
Targeted therapies are newer cancer treatments. They work by blocking specific proteins that help cancer cells grow, multiply, and spread. Different targeted therapies work for different types of cancer.
Since targeted therapies work directly on cancer cells, they don’t affect healthy cells as much as chemotherapy does. This means they tend to have fewer side effects than chemotherapy. However, side effects† are still possible with these drugs.
* For more information about the approved use of Rybrevant, see the “Rybrevant uses” section below.
† To read more about Rybrevant’s side effects, see the “Rybrevant side effects” section above.
Rybrevant is a targeted therapy for a specific form of non-small cell lung cancer with epidermal growth factor receptors (EGFR-positive NSCLC).* Targeted therapies block specific proteins that help cancer cells grow, multiply, and spread. Rybrevant is a type of targeted therapy called bispecific antibodies. “Bispecific” means that the drug can bind to two different proteins at the same time.
Other drugs are available that can treat your condition. Some may be a better fit for you than others. If you’re interested in finding an alternative to Rybrevant, talk with your doctor. They can tell you about other medications that may work well for you.
Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label drug use is when a drug that’s approved by the Food and Drug Administration (FDA) is used for a purpose other than what it’s approved for.
* To read more about Rybrevant’s approved use, see “Rybrevant uses” below.
Alternatives for non-small cell lung cancer
Examples of other drugs that may be prescribed to treat NSCLC include:
- other EGFR inhibitors, such as:
- immunotherapies (treatments that help your immune system attack cancer cells), such as:
- chemotherapies, such as:
- carboplatin
- cisplatin
- docetaxel (Taxotere)
- doxorubicin (Doxil)
- gemcitabine (Infugem)
- methotrexate (Trexall, Rasuvo, others)
- paclitaxel (Abraxane)
- vinorelbine
The Food and Drug Administration (FDA) approves prescription drugs, such as Rybrevant, to treat certain conditions.
Rybrevant for non-small cell lung cancer
Rybrevant is approved to treat a specific form of non-small cell lung cancer with epidermal growth factor receptors (EGFR-positive NSCLC). It’s approved for use in adults.
With EGFR-positive NSCLC, your cancer cells have abnormal EGFRs on their surface. EGFRs are proteins that usually tell your cells to grow and divide. However, they can become abnormal due to genetic mutations (unusual changes in a gene). When this happens, they tell cells to grow and multiply (increase in numbers) in an unmanaged way. This leads to cancer.
Lung cancer cells make abnormal EGFR proteins on their surface if they have certain genetic mutations. Rybrevant is prescribed specifically for EGFR-positive cancer that has genetic mutations called exon 20 insertions.
Rybrevant is prescribed when EGFR-positive NSCLC:
- is locally advanced (spread into nearby tissues) or metastatic (spread to other parts of the body, such as the bones), and
- has gotten worse during or after treatment with a platinum-based drug (a type of chemotherapy)
Your doctor will order specific tests to determine which type of lung cancer you have. These tests, sometimes called biomarker tests, are approved by the FDA. And they’ll help your doctor determine whether Rybrevant is right for your condition.
To learn more about lung cancer and its treatment, visit our lung cancer hub. You can also talk with your doctor.
Effectiveness for non-small cell lung cancer
Rybrevant is an effective treatment for the specific form of NSCLC described above. The National Comprehensive Cancer Network guidelines recommend Rybrevant to treat this form of NSCLC.
To find out how Rybrevant performed in clinical trials, see the drug’s prescribing information.
Rybrevant and children
Rybrevant isn’t approved for use in children. It’s not known whether it’s safe or effective for use in children.
Rybrevant isn’t known to interact with alcohol. However, drinking alcohol could worsen certain side effects of Rybrevant treatment. These include headache, nausea, vomiting, diarrhea, dizziness, and fatigue. (For details about Rybrevant’s side effects, see the “Rybrevant side effects” section above.)
If you drink alcohol, ask your doctor how much, if any, is safe to drink during Rybrevant treatment.
Rybrevant isn’t known to interact with other medications, herbs, supplements, or foods. The manufacturer of Rybrevant didn’t look at interactions in clinical trials of the drug.
However, this doesn’t mean that interactions can’t happen with Rybrevant.
Before starting Rybrevant treatment, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also, tell them about any vitamins, herbs, and supplements you take. Sharing this information can help you avoid potential interactions.
If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.
You’ll receive Rybrevant as an intravenous (IV) infusion in your doctor’s clinic or an infusion center. Your doctor or another healthcare professional will give your infusion.
The first two Rybrevant infusions will usually take about 4–6 hours. After this, they’ll typically take about 2–4 hours.
Your first two infusions are given more slowly to help prevent infusion-related reactions.* This is a possible side effect of Rybrevant. You’ll also be given certain medications before each Rybrevant infusion to help prevent these reactions. These include:
- an antihistamine, such as diphenhydramine (Benadryl)
- a medication to reduce fever, such as acetaminophen (Tylenol)
- a corticosteroid, such as dexamethasone or methylprednisolone
* To read more about infusion-related reactions, see the “Rybrevant side effects” section above.
When you’ll receive Rybrevant
In week 1 of treatment, you’ll receive your recommended dose split between two separate infusions. You’ll have your first half of the infusion on day 1 and your second half of the infusion on day 2.
In weeks 2–4 of treatment, you’ll typically receive your full recommended dose as one infusion per week. This will be on day 1. And after this, you’ll receive your full recommended dose given once every 2 weeks.
To help make sure that you don’t miss an infusion appointment, be sure to add your treatment schedule to your calendar. You could also download a reminder app on your phone.
Rybrevant is not safe to receive during pregnancy. The drug could harm a fetus if given to someone who is pregnant. This is based on the way the drug works and results from animal studies.
If you can become pregnant, you should take a pregnancy test before you start Rybrevant treatment.
If you are pregnant or plan to become pregnant, your doctor will likely not prescribe Rybrevant. Talk with your doctor about other possible treatment options for your condition.
Rybrevant is not safe to receive during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re receiving Rybrevant.
For females receiving Rybrevant
If you’re female* and can become pregnant, you should use birth control while receiving Rybrevant. You should also use it for 3 months after your last dose.
For males receiving Rybrevant
The manufacturer doesn’t give birth control recommendations for males* receiving Rybrevant. If you’re male and have a sexual partner who’s able to become pregnant, talk with your doctor about your birth control needs.
For more information about receiving Rybrevant during pregnancy, see the “Rybrevant and pregnancy” section above.
* Sex and gender exist on spectrums. Use of the terms “male” and “female” in this article refers to sex assigned at birth.
You should not breastfeed while receiving Rybrevant treatment and for 3 months after your last dose.
It’s not known whether Rybrevant passes into breast milk. If it does, it could have serious side effects in a child who is breastfed.
If you’re breastfeeding or planning to breastfeed, talk with your doctor about the best ways to feed your child while you’re receiving Rybrevant.
This drug comes with several precautions. Before receiving Rybrevant, talk with your doctor about your health history. Rybrevant may not be right for you if you have certain medical conditions or other factors affecting your health. These include:
- Allergic reaction. If you’ve had an allergic reaction to Rybrevant or any of its ingredients, your doctor will likely not prescribe the drug. Ask your doctor what other medications are better options for you.
- Pregnancy. Rybrevant is not safe to receive during pregnancy. For more information, see the “Rybrevant and pregnancy” section above.
- Breastfeeding. You should not breastfeed while receiving Rybrevant and for 3 months after your last dose. For more information, see the “Rybrevant and breastfeeding” section above.
Note: For more details about the potential negative effects of Rybrevant, see the “Rybrevant side effects” section above.
Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.