| Common Brands | Rybrevant |
|---|---|
|
Drug Class |
Monoclonal Antibody |
|
Controlled Substance Classification |
Not a controlled medication |
|
Generic Status |
Lower-cost generic available |
|
Availability |
Prescription only |
Amivantamab is the brand name for the drug marketed under the brand name Rybrevant. It is a new targeted therapy that has been developed by Janssen Biotech, which is a subsidiary of Johnson & Johnson. The U.S. Food and Drug Administration (FDA) approved this in May 2021 to treat adult patients suffering from NSCLC with EGFR exon 20 insertion mutations. This drug falls into the category of bispecific antibodies as it binds and inhibits two different targets simultaneously: the EGFR and MET receptors.
This medication was developed for therapy use in advanced or metastatic NSCLC wherein first-line treatments, for instance chemotherapy or EGFR TKIs, have failed to exert an effect or the appropriate therapy was not determined.
Its approval is such an advancement in precision oncology that offers a drug opportunity for patients whose specific tumors have mutations that might prove difficult to treat conventionally.
Administration: Amivantamab is given intravenously through the health care provider. Usually, treatment takes place in a hospital or clinic because of possible infusion reactions and the monitoring of infusion.
Administration Timing
It is usually dosed once a week during the first four weeks. Then, after the month, the dose is normally decreased to once every two weeks.
This can depend on the patient’s weight, among other medical conditions. Based on the patient’s response to the treatment and their ability to tolerate it, the health care provider will modify the dose.
Amivantamab is a bispecific monoclonal antibody that has been designed to target and inhibit the activity of two receptors, namely EGFR and MET, which are frequently implicated in the growth and spread of cancer cells.
The drug is engineered to be bispecific, meaning it targets both EGFR and MET, allowing it to address two potential pathways that may drive the growth of cancer cells in NSCLC.
Amivantamab is primarily indicated for patients harboring EGFR exon 20 insertion mutations, a challenging mutation to treat with standard EGFR-targeted therapies. It can also be used for patients harboring other mutations, such as those involving MET, that confer cancer resistance against other therapies. The drug is given intravenously (IV) in a clinical setting, usually as part of a treatment regimen for advanced cancer.
Amivantamab mechanism of action centers around its capacity to bind both the EGFR and MET receptors that are typically overexpressed or mutated in a wide variety of cancers, including NSCLC. Here is how it works:
EGFR Targeting: EGFR is a cell surface receptor and is important for cell division and survival. Mutations in EGFR are associated with most cancers and cause cells to grow uncontrollably. Amivantamab binds to the EGFR receptor, thereby blocking downstream signaling pathways that promote tumor growth.
MET Targeting: The MET receptor is involved in cell growth, survival, and metastasis. Overexpression of MET is often associated with resistance to EGFR-targeted therapies. Amivantamab binds to MET receptors as well, preventing MET-driven signaling that would otherwise enhance tumor progression.
By targeting both these receptors, Amivantamab will effectively block multiple pathways that have been driving the survival and proliferation of cancer cells. Therefore, it is a highly potent therapy, especially in patients with tumors that are mutated to resist standard EGFR inhibitors.
Like all cancer treatments, Amivantamab may cause side effects. The most common side effects for this drug are as follows:
Infusion-related reactions: These are reactions that may occur while giving the drug. The symptoms of these reactions can include fever, chills, nausea, headache, and shortness of breath. These reactions are usually controllable with premedication and monitoring.
Skin Rash: Common side effect of EGFR inhibitors that can appear like acne-like rashes or dry skin.
Diarrhea: This is another possible side effect that can be associated with many targeted therapies, including Amivantamab.
Fatigue: As with most cancer therapies, the patient may suffer from fatigue or weakness.
Pneumonitis: A serious but rare lung condition that can cause inflammation, difficulty breathing, or coughing.
Electrolyte Imbalance: Low levels of potassium, magnesium, or calcium in the blood.
Patients should inform their treating health care provider of their known medical conditions, especially:
Lung disease or difficulties with breathing: Because of potential pneumonitis, anyone with a history of pulmonary disease should be followed up closely.
Heart conditions: Infusion reactions are often associated with Amivantamab and can present as cardiovascular events, for instance, hypotension and tachycardia.
Allergic reactions: Amivantamab can cause severe allergic reactions called anaphylaxis; patients must seek medical help right away.
Pregnancy and Breastfeeding: Amivantamab must not be used by a pregnant woman because it might cause harm to a baby developing in the womb. Women who are pregnant or breastfeeding should consult with their physician for alternative treatment.
Amivantamab has a number of notable advantages that make it an important treatment for certain NSCLC patients:
Targeted Therapy: By specifically targeting the EGFR and MET receptors, Amivantamab offers a more tailored treatment compared to traditional chemotherapy, which indiscriminately attacks both cancerous and healthy cells.
Efficacy in EGFR Exon 20 Mutations: EGFR exon 20 insertion mutations represent a common resistance mechanism to both first-line and second-line EGFR inhibitors. There has been promising clinical efficacy with amivantamab in the context of this particular mutation, offering much-needed options for patients whose options previously were limited.
Dual Action: The bispecific nature of the drug allows it to target two of the major drivers of NSCLC; this enhances the potential effectiveness to treat tumor resistance to one-target therapy.
The dose of Amivantamab is based on the patient’s weight and the specifics of their condition. For adult patients with EGFR exon 20 insertion mutations:
Initial Dose: 1050 mg for patients weighing less than 80 kg; 1400 mg for patients weighing 80 kg or more.
Maintenance Dose: A maintenance dose of 1400 mg is administered every two weeks in patients weighing less than 80 kg, while for patients weighing more than 80 kg, it is 2100 mg.
Dosage adjustment should be done based on patient’s response and any adverse reactions that occur.
Amivantamab is a prescription-only medication, available only through healthcare providers who are familiar with its use. It is not available for over-the-counter purchase, and its use requires careful medical supervision, given the potential for side effects and the complexity of administration. It is primarily prescribed by oncologists or healthcare professionals specializing in cancer treatment.
Patients are also required to undergo genetic testing to confirm the presence of EGFR exon 20 insertion mutations or other eligible mutations before treatment with Amivantamab.
Amivantamab is a bispecific monoclonal antibody designed to treat non-small cell lung cancer (NSCLC) with specific mutations, notably EGFR exon 20 insertions.
Amivantamab targets and binds to both EGFR (epidermal growth factor receptor) and MET (mesenchymal-epithelial transition factor), inhibiting cancer cell growth and promoting immune system response against tumor cells.
Amivantamab is primarily used for adult patients with NSCLC that has specific EGFR exon 20 insertion mutations who have received prior systemic therapy.
Amivantamab binds to EGFR and MET, blocking their signaling pathways that promote tumor growth and survival. It also recruits immune cells to help destroy cancer cells.
Common side effects may include rash, fatigue, nausea, diarrhea, and infusion-related reactions. Serious side effects can include interstitial lung disease and liver enzyme elevation.
Amivantamab is given intravenously (IV). The treatment typically involves an initial dose, followed by maintenance doses every two weeks.
Patients with a known hypersensitivity to Amivantamab or any of its components should not receive this medication. Pregnant or breastfeeding women should also avoid it due to potential risks to the fetus or infant.
Amivantamab can be used alongside other therapies, but this should be done under the guidance of an oncologist to manage potential interactions and side effects.
Patients usually need genetic testing for EGFR mutations to confirm the presence of exon 20 insertions before starting treatment.
The duration of treatment with Amivantamab depends on the patient’s response to therapy and the occurrence of any side effects. Regular assessments will guide treatment decisions.
Patients should contact their healthcare provider for guidance. It’s usually recommended to reschedule as soon as possible, but patients should not double up on doses.
There are no specific dietary restrictions associated with Amivantamab, but patients should maintain a healthy diet and discuss any concerns with their healthcare team.
Patients will be monitored for their overall response to treatment and side effects, including lung function tests and liver function tests, especially in the first few months.
Yes, rash is a common side effect of Amivantamab. Management may include topical treatments, antihistamines, and sometimes corticosteroids, as directed by a healthcare provider.
Clinical trials have shown promising results for Amivantamab in patients with NSCLC harboring EGFR exon 20 insertions, with response rates observed in a significant proportion of patients.
Patients should report any new or worsening symptoms, particularly respiratory symptoms, fever, rash, or symptoms indicating liver issues, such as jaundice.
Coverage may vary by insurance provider. Patients should check with their insurance company to understand coverage details and any associated costs.
Long-term effects are still being studied, but potential effects can include persistent rash and lung-related issues. Regular follow-ups will help identify any long-term complications.
There is limited data on the impact of Amivantamab on fertility. Patients interested in family planning should discuss this with their healthcare provider.
Patients can find more information from their healthcare provider, drug manufacturer websites, and reputable medical resources like the American Cancer Society or ClinicalTrials.gov.
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