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Amivantamab IV
Amivantamab IV is a EGFR inhibitor Small molecule drug developed by Janssen Research & Development, LLC. It is currently in Phase 2 development for Non-small cell lung cancer. Also known as: JNJ-61186372, RYBREVANT.
Targeting EGFR
Amivantamab IV is an epidermal growth factor receptor (EGFR) inhibitor, classified as an antibody-based inhibitor. It is being studied in clinical trials for various conditions, including metastatic non-small cell lung cancer, squamous cell carcinoma of the head and neck, and advanced solid tumors.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 2 attrition
-2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies. -
Big-pharma sponsor
+3.0pp
Janssen Research & Development, LLC is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Amivantamab IV |
|---|---|
| Also known as | JNJ-61186372, RYBREVANT |
| Sponsor | Janssen Research & Development, LLC |
| Drug class | EGFR inhibitor |
| Target | EGFR |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
Amivantamab is a fully human monoclonal antibody that targets the extracellular domain of EGFR mutations, including exon 20 insertions.
Approved indications
- Non-small cell lung cancer
Common side effects
- Interstitial lung disease
- Pneumonitis
- Fatigue
- Nausea
- Diarrhea
Key clinical trials
- Treatment With Amivantamab and Hyaluronidase or Cetuximab for Advanced Skin Cancer in People With a Weakened Immune System (PHASE2)
- A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) (PHASE2)
- A Study to Investigate Safety and Efficacy of Osimertinib and Amivantamab in Participants With Non-small Cell Lung Cancer With Common Epidermal Growth Factor Receptor Mutations (PHASE2)
- A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions (PHASE3)
- A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer (PHASE1, PHASE2)
- A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer (PHASE1)
- Premedication to Reduce Amivantamab Associated Infusion Related Reactions (PHASE2)
- A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Amivantamab IV CI brief — competitive landscape report
- Amivantamab IV updates RSS · CI watch RSS
- Janssen Research & Development, LLC portfolio CI
Frequently asked questions about Amivantamab IV
What is Amivantamab IV?
How does Amivantamab IV work?
What is Amivantamab IV used for?
Who makes Amivantamab IV?
Is Amivantamab IV also known as anything else?
What drug class is Amivantamab IV in?
What development phase is Amivantamab IV in?
What are the side effects of Amivantamab IV?
What does Amivantamab IV target?
Related
- Drug class: All EGFR inhibitor drugs
- Target: All drugs targeting EGFR
- Manufacturer: Janssen Research & Development, LLC — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Non-small cell lung cancer
- Also known as: JNJ-61186372, RYBREVANT
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing