Subcutaneous Amivantamab Availability
The subcutaneous formulation of amivantamab has been established as non-inferior to intravenous administration and is currently being used in clinical trials, but specific regulatory approval timelines and geographic availability depend on local regulatory agencies (FDA, EMA, or other national authorities) and have not been publicly disclosed in the available evidence.
Current Status of Subcutaneous Amivantamab
Clinical Trial Evidence
- The phase III PALOMA-3 study demonstrated non-inferiority of subcutaneous amivantamab compared to intravenous formulation in 418 patients with EGFR mutation-positive NSCLC 1
- Subcutaneous administration showed significantly fewer infusion-related reactions (13% vs 66%), shorter administration time, and higher patient satisfaction compared to IV formulation 1
- Pharmacokinetic properties, objective response rate, and progression-free survival were similar between subcutaneous and intravenous routes 1
Current Clinical Use
- Subcutaneous amivantamab is being actively studied in ongoing trials, including the OrigAMI-4 study for head and neck cancer, where it demonstrated tolerability with only 7% administration-related reactions 2
- The subcutaneous formulation uses weight-based dosing: 1600 mg (2240 mg for ≥80 kg) on Cycle 1 Day 1, then 2400 mg (3360 mg for ≥80 kg) thereafter 2
Regulatory Approval Status
Currently Approved Formulations
- Intravenous amivantamab-vmjw is FDA-approved for EGFR exon 20 insertion mutations in locally advanced or metastatic NSCLC after platinum-based chemotherapy 1
- IV amivantamab plus carboplatin-pemetrexed is approved as first-line therapy for EGFR exon 20 insertions 1, 3
- Current IV dosing is 1,050 mg (body weight <80 kg) or 1,400 mg (≥80 kg) weekly for 4 weeks, then every 2 weeks 4
Subcutaneous Formulation Approval
The evidence does not specify when subcutaneous amivantamab will receive regulatory approval or become commercially available in any specific location. The PALOMA-3 data from 2024 establishes the scientific basis for approval, but regulatory review timelines vary by jurisdiction 1
Practical Considerations
Advantages of Subcutaneous Formulation
- Dramatically reduced infusion-related reactions: 13% vs 66% with IV administration 1
- Shorter administration time compared to IV infusion, which can take 4.70-5.08 hours for the first dose 4
- Improved patient satisfaction and convenience 1
- Exploratory overall survival data showed improvement (HR 0.62, P=0.02) 1
Current Treatment Options While Awaiting SC Approval
- Patients requiring amivantamab should receive the currently approved IV formulation rather than delaying treatment 1, 3
- IV amivantamab remains a Category 1, preferred first-line option for EGFR exon 20 insertions when combined with chemotherapy 1, 3
- Infusion-related reactions with IV formulation occur in 66% of patients but are manageable with premedication, dose modifications, and close monitoring 4, 5
Important Caveats
To determine specific availability in your location, you must:
- Contact your local regulatory authority (FDA for United States, EMA for Europe, etc.) for approval status
- Check with the manufacturer (Janssen Research and Development) for regional launch timelines 6
- Consult your institutional pharmacy or oncology department for access to clinical trials if commercial approval is pending
The evidence confirms subcutaneous amivantamab is clinically validated and superior in tolerability, but regulatory pathways and commercial availability timelines are not addressed in the clinical literature reviewed 1, 2.