Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

32
Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
32
Pharmacovigilance01:19

Pharmacovigilance

1.2K
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
1.2K
Therapeutic Drug Monitoring: Overview and Classification01:16

Therapeutic Drug Monitoring: Overview and Classification

52
Therapeutic Drug Monitoring (TDM) is a clinical practice that measures specific drug levels in a patient's blood at designated intervals to ensure the drug concentration stays within a therapeutic range. This monitoring is crucial for optimizing individual dosage regimens, enhancing therapeutic efficacy, and minimizing drug-related toxicity. TDM is vital for drugs with narrow therapeutic windows, significant variability in pharmacokinetics, and a clear correlation between plasma levels and...
52
Prescription, Nonprescription and Orphan Drugs01:02

Prescription, Nonprescription and Orphan Drugs

965
Prescription drugs require a prescription from a medical practitioner and can only be obtained from a pharmacy. They have many applications, including treating pain, anxiety, and hypertension.
The misuse and addiction to prescription drugs is a growing problem that can affect people of all age groups, specifically teenagers. This can happen when prescription medications are used in ways not intended by the prescriber, such as taking someone else's prescription or using medication for...
965
Drug Administration and Therapy Phases: Overview01:26

Drug Administration and Therapy Phases: Overview

893
Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
893
Preclinical Development: Overview01:28

Preclinical Development: Overview

5.3K
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
5.3K

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Culmerciclib: First Approval.

Drugs·2026
Same author

Correction: Plozasiran: First Approval.

Drugs·2026
Same author

Durvalumab: A Review in Limited-Stage Small Cell Lung Cancer.

Targeted oncology·2026
Same author

Plozasiran: First Approval.

Drugs·2026
Same author

Puzolcabtagene Autoleucel: Pediatric First Approval.

Paediatric drugs·2026
Same author

Donidalorsen: First Approval.

Drugs·2025

Related Experiment Video

Updated: Oct 27, 2025

Author Spotlight: Magnetic Fluorescent Bead-Based Dual-Reporter Flow Analysis of PDL1-Vaxx Peptide Vaccine-Induced Antibody Blockade of the PD-1/PD-L1 Interaction
10:18

Author Spotlight: Magnetic Fluorescent Bead-Based Dual-Reporter Flow Analysis of PDL1-Vaxx Peptide Vaccine-Induced Antibody Blockade of the PD-1/PD-L1 Interaction

Published on: July 7, 2023

1.5K

Amivantamab: First Approval.

Yahiya Y Syed1

  • 1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.

Drugs
|July 22, 2021
PubMed
Summary

Amivantamab, a novel bispecific antibody for non-small cell lung cancer (NSCLC), targets EGFR and MET. It received US approval for NSCLC with specific EGFR mutations after chemotherapy failure.

Area of Science:

  • Oncology
  • Pharmacology
  • Molecular Biology

Background:

  • Non-small cell lung cancer (NSCLC) remains a leading cause of cancer-related mortality worldwide.
  • Epidermal growth factor receptor (EGFR) exon 20 insertion mutations are a rare but aggressive subset of NSCLC with limited treatment options.
  • Targeted therapies have revolutionized NSCLC treatment, but novel approaches are needed for resistant mutations.

Purpose of the Study:

  • To summarize the key developmental milestones of amivantamab, a bispecific monoclonal antibody.
  • To highlight the regulatory pathway leading to the US approval of amivantamab for specific NSCLC patient populations.
  • To provide an overview of amivantamab's mechanism of action and therapeutic potential in NSCLC.

Main Methods:

  • Review of preclinical studies and clinical trial data for amivantamab.

More Related Videos

A Real-time Potency Assay for Chimeric Antigen Receptor T Cells Targeting Solid and Hematological Cancer Cells
08:46

A Real-time Potency Assay for Chimeric Antigen Receptor T Cells Targeting Solid and Hematological Cancer Cells

Published on: November 12, 2019

53.6K
Initial Evaluation of Antibody-conjugates Modified with Viral-derived Peptides for Increasing Cellular Accumulation and Improving Tumor Targeting
11:58

Initial Evaluation of Antibody-conjugates Modified with Viral-derived Peptides for Increasing Cellular Accumulation and Improving Tumor Targeting

Published on: March 8, 2018

7.8K

Related Experiment Videos

Last Updated: Oct 27, 2025

Author Spotlight: Magnetic Fluorescent Bead-Based Dual-Reporter Flow Analysis of PDL1-Vaxx Peptide Vaccine-Induced Antibody Blockade of the PD-1/PD-L1 Interaction
10:18

Author Spotlight: Magnetic Fluorescent Bead-Based Dual-Reporter Flow Analysis of PDL1-Vaxx Peptide Vaccine-Induced Antibody Blockade of the PD-1/PD-L1 Interaction

Published on: July 7, 2023

1.5K
A Real-time Potency Assay for Chimeric Antigen Receptor T Cells Targeting Solid and Hematological Cancer Cells
08:46

A Real-time Potency Assay for Chimeric Antigen Receptor T Cells Targeting Solid and Hematological Cancer Cells

Published on: November 12, 2019

53.6K
Initial Evaluation of Antibody-conjugates Modified with Viral-derived Peptides for Increasing Cellular Accumulation and Improving Tumor Targeting
11:58

Initial Evaluation of Antibody-conjugates Modified with Viral-derived Peptides for Increasing Cellular Accumulation and Improving Tumor Targeting

Published on: March 8, 2018

7.8K
  • Analysis of regulatory submissions and approval processes.
  • Summary of amivantamab's unique bispecific antibody design targeting EGFR and MET.

    • Main Results:

    • Amivantamab (amivantamab-vmjw; Rybrevant™) received US FDA approval on May 21, 2021.
    • Approval is for adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations.
    • Patients must have progressed on or after platinum-based chemotherapy.

    Conclusions:

    • Amivantamab represents a significant advancement in targeted therapy for NSCLC patients with EGFR exon 20 insertion mutations.
    • The development and approval of amivantamab underscore the importance of targeting specific genetic alterations in cancer.
    • Further global regulatory reviews are ongoing, indicating broader potential for this novel therapy.