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RYBREVANT FASPRO™

(amivantamab and hyaluronidase-lpuj)

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RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj)

Medical Information

Safety Information for RYBREVANT FASPRO - Administration-Related Reactions

Last Updated: 12/17/2025

SUMMARY

  • RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) for subcutaneous (SC) administration is a coformulation of amivantamab with recombinant human hyaluronidase PH20 (rHuPH20).1
  • RYBREVANT (amivantamab-vmjw) is a low fucose, fully human, immunoglobulin G1 (IgG1)-based bispecific antibody with immune cell-directing activity that targets epidermal growth factor receptor (EGFR) mutations and mesenchymal-epithelial transition (MET) mutations and amplifications in non-small cell lung cancer (NSCLC).2
  • LAZCLUZE (lazertinib) is a third-generation EGFR tyrosine kinase inhibitor.3
  • PALOMA-3 (NCT05388669) is a phase 3, open-label, international, randomized study evaluating the pharmacokinetics (PK), efficacy, and safety of RYBREVANT FASPRO plus LAZCLUZE (n=206) vs RYBREVANT plus LAZCLUZE (n=212) in patients with EGFR-mutated (Exon 19 deletion [Exon19del] or Exon 21 L858R) locally advanced or metastatic NSCLC who experienced disease progression on or after osimertinib and platinum-based chemotherapy (N=418).1,4
    • All-grade infusion-related reactions (IRRs) were reported by 13% of patients in the RYBREVANT FASPRO plus LAZCLUZE group and by 66% of patients in the RYBREVANT plus LAZCLUZE group (Table: PALOMA-3: Incidence of IRRs).1
  • PALOMA-2 (NCT05498428) is an ongoing, phase 2, open-label, international, parallel-cohort study evaluating the efficacy and safety of RYBREVANT FASPRO with chemotherapy and/or LAZCLUZE combination therapy in patients with EGFR-mutated advanced NSCLC (N=520).5,6
    • In cohorts 1 and 6, all-grade administration-related reactions (ARRs) were reported in 15% of patients in the RYBREVANT FASPRO plus LAZCLUZE group.5
    • In cohort 2, ARRs were reported in 6% of patients in the RYBREVANT FASPRO plus chemotherapy group.7
    • In cohort 3b, ARRs were reported in 8% of patients in the RYBREVANT FASPRO plus chemotherapy group.8
    • In cohort 4, no ARRs were reported in patients who switched from RYBREVANT to RYBREVANT FASPRO.9
    • In cohort 5, ARRs were reported in 12% of patients in the RYBREVANT FASPRO plus LAZCLUZE group.10
  • For medical management of administration- or infusion-related reactions in the
  • PALOMA-3 study, refer to Guidelines for the Monitoring, Prevention, and Management of Administration- or Infusion-Related Reactions in the PALOMA-3 study.
  • Please refer to RYBREVANT FASPRO, RYBREVANT, and LAZCLUZE product labeling for complete safety information, including dose modification guidelines for adverse reactions.

PRODUCT LABELING

CLINICAL DATA

PALOMA-3 Study

Study Design/Methods

  • Phase 3, randomized, open-label, international study designed to assess the PK, efficacy, and safety of RYBREVANT FASPRO plus LAZCLUZE (n=206) vs RYBREVANT plus LAZCLUZE (n=212) in patients with EGFR-mutated (Exon19del or Exon 21 L858R) locally advanced or metastatic NSCLC who experienced disease progression on or after osimertinib and platinum-based chemotherapy (N=418).1,4
    • RYBREVANT FASPRO 1600 mg SC (2240 mg if body weight [BW] ≥80 kg) was administered once weekly (QW) for the first 4 weeks and then once every 2 weeks (Q2W) thereafter.
    • RYBREVANT 1050 mg intravenous (IV; 1400 mg if BW ≥80 kg) was administered QW for the first 4 weeks and then Q2W thereafter.
    • LAZCLUZE 240 mg orally (PO) was administered once daily.

Results

  • At a median follow-up of 7 months (range, 0.1-14.4), the median duration of treatment was 4.7 months (range, 0.1-13.2) for RYBREVANT FASPRO plus LAZCLUZE and 4.1 months (range, 0-13.2) for RYBREVANT plus LAZCLUZE.1
  • IRRs cover a range of symptoms or systemic reactions that can occur in response to the infusion or administration of amivantamab, such as chills, dyspnea, chest discomfort, fever, and flushing. In the PALOMA-3 study, where patients were randomized to receive either RYBREVANT FASPRO or RYBREVANT, these reactions were consistently recorded as IRRs to maintain sponsor blinding. IRRs reported in the RYBREVANT FASPRO plus LAZCLUZE treatment group were considered as a systemic reaction related to SC administration.11
  • The median time to onset of first IRR (calculated as the time from the most recent amivantamab administration to the start of IRR) in the RYBREVANT FASPRO plus LAZCLUZE treatment group was 105 minutes (range, 0-2056).12
  • All-grade IRRs were reported by 13% of patients in the RYBREVANT FASPRO plus LAZCLUZE group and by 66% of patients in the RYBREVANT plus LAZCLUZE group.1
    • No grade 4-5 IRRs were reported.
    • Most IRRs were reported during cycle 1.
  • The incidence of IRRs reported in the PALOMA-3 study is shown in the table below.

PALOMA-3: Incidence of IRRs1
IRR
RYBREVANT FASPRO + LAZCLUZE
(n=206)
RYBREVANT + LAZCLUZE
(n=210)
All-grade IRRs, %
13
66
Grade ≥3 IRRs, n (%)
1 (0.5)
8 (4)
IRRs leading to discontinuations, n (%)
0
4 (2)
Abbreviations: IRR, infusion-related reaction.
  • The incidence rate of infusion-related adverse events (AEs) ranged between 0% and 6% in the RYBREVANT FASPRO plus LAZCLUZE group and between 2% and 20% in the RYBREVANT plus LAZCLUZE group.1
  • Infusion-related AEs reported in the PALOMA-3 study are shown in the table below.

PALOMA-3: Infusion-Related AEs1
Infusion-Related AE, %
RYBREVANT FASPRO + LAZCLUZE
(n=206)
RYBREVANT + LAZCLUZE
(n=210)
Chills
6
14
Pyrexia
3
3
Dyspnea
3
20
Nausea
3
20
Vomiting
2
15
Cough
2
8
Hypoxia
2
9
Sinus tachycardia
2
5
Hypotension
1
8
Erythema
1
3
Chest discomfort
0.5
6
Hypertension
0.5
6
Flushing
0
12
Dizziness
0
4
Rash
0
3
Hyperhidrosis
0
2
Increased heart rate
0
2
Abbreviation: AE, adverse event.
Note: The safety population included all patients who had undergone randomization and received ≥1 dose of any trial treatment.

PALOMA-2 Study

Study Design/Methods

  • Phase 2, ongoing, parallel-cohort, open-label, international study designed to assess the efficacy and safety of RYBREVANT FASPRO with chemotherapy and/or LAZCLUZE in patients with EGFR-mutated advanced NSCLC (N=520).5,6
    • Cohorts 1 and 6: RYBREVANT FASPRO 1600 mg SC (2240 mg if BW ≥80 kg) was administered QW for the first 4 weeks and then Q2W thereafter. LAZCLUZE 240 mg PO was administered once daily.5
    • Cohort 2: RYBREVANT FASPRO 1600 mg SC (2240 mg if BW ≥80 kg) was administered on cycle 1 day 1, then 2400 mg (3360 mg if BW ≥80 kg) on days 8 and 15 of cycle 1, and then Q3W thereafter. Carboplatin area under the curve 5 (AUC5, for a maximum of 4 cycles) and pemetrexed 500 mg/m2 until disease progression were administered on day 1 of each 21-day cycle.7 
    • Cohort 3b: RYBREVANT FASPRO 1600 mg SC (2240 mg if BW ≥80 kg) was administered on cycle 1 day 1, then 2400 mg (3360 mg if BW ≥80 kg) on days 8 and 15 of cycle 1, and then Q3W thereafter. Carboplatin AUC5 (for a maximum of 4 cycles) and pemetrexed 500 mg/m2 until disease progression were administered on day 1 of each 21-day cycle8
    • Cohort 4: Of the 26 patients enrolled, 25 were switched from RYBREVANT to RYBREVANT FASPRO. Patients in cohort 4 previously received RYBREVANT for ≥8 weeks without dose reduction or evidence of progressive disease, as part of standard of care, an expanded access program, or rollover from a long-term extension study. RYBREVANT FASPRO 1600 mg SC (2240 mg if BW ≥80 kg) was administered on days 1 and 15 of each 28-day cycle with or without LAZCLUZE.9
    • Cohort 5: RYBREVANT FASPRO 1600 mg SC (2240 mg if BW ≥80 kg) was administered QW for the first 4 weeks, and then 3520 mg (4640 mg if BW ≥80 kg) Q4W thereafter (28-day cycles). LAZCLUZE 240 mg PO was administered once daily.10

Results

  • As amivantamab was administered SC in the PALOMA-2 study, the term ARR is used to describe the systemic reactions associated with SC administration, such as fever, chills, rigors, bronchospasm, headache, rash, pruritus, arthralgia, and hypo- or hypertension.13
  • Cohorts 1 and 6: At a median follow-up of 8.6 months, ARRs were reported in 15% (19/125) of patients with an Exon19del or Exon 21 L858R mutation.5
    • The median time to ARR onset (defined as the start of ARR minus the start of the last injection prior to this event) was 2.3 hours (range, 0.3-7.2).
    • ARRs (90%; 18/20) were mostly reported during cycle 1 (on or after cycle 1 day 1 but before the next dose).
    • One patient reported 2 ARRs (1 on cycle 1 day 1 and 1 on cycle 1 day 9).
  • Cohort 2: At a median follow-up of 10.4 months (data cutoff: October 24, 2024), ARRs (defined per the Medical Dictionary for Regulatory Activities [MedDRA] preferred term and referred to as IRRs in prior IV studies) were reported in 4 (6%) patients with Exon 20 insertion mutation.7 
    • The median time to ARR onset was 1.6 hours (range, 0.7-2.4), and median duration of ARR was 7.2 hours (range, 0.3-14).
    • All the ARRs occurred at the first injection (on or after cycle 1 day 1 but before the next dose).
    • No grade ≥3 ARRs were reported.
    • Rate of ARRs was 7-fold lower compared with previous reports of RYBREVANT IV Q3W plus chemotherapy.
  • Cohort 3b: At a median follow-up of 7 months (data cutoff: October 24, 2024), ARRs (defined per the MedDRA preferred term and referred to as IRRs in prior IV studies) were reported in 6 (8%) patients with Exon19del or Exon 21 L858R mutation.8
    • The median time to ARR onset was 2.7 hours (range, 1.1-6.3), and median duration of ARR was 2.7 hours (range, 0.1-6.1).
    • All the ARRs occurred and were resolved on C1D1.
    • No grade ≥3 ARRs were reported.
    • Rate of ARRs was ~7-fold lower compared with previous reports of RYBREVANT IV Q3W plus chemotherapy.
  • Cohort 4: At a median follow-up of 9.7 months (data cutoff: October 24, 2024), no ARRs were reported.9
  • Cohort 5: At a median follow-up of 6.5 months (data cutoff: October 24, 2024), ARRs (defined per the MedDRA preferred term and referred to as IRRs in prior IV studies) were reported in 9 (12%) patients with Exon19del or Exon 21 L858R mutation.10 
    • ARRs (78%; 7/9) mostly occurred at the first injection (on or after cycle 1 day 1 but before the next dose).
    • One patient (1%) reported grade ≥3 ARR.
    • Rate of ARRs was ~5-fold lower compared with previous reports of RYBREVANT IV Q2W plus LAZCLUZE.

GUIDELINES FOR THE MONITORING, PREVENTION, AND MANAGEMENT OF ADMINISTRATION- OR INFUSION-RELATED REACTIONS IN THE PALOMA-3 STUDY

The information provided in this section summarizes interventions investigators in the PALOMA-3 study were instructed to perform to monitor and manage ARRs/IRRs. These are not recommendations for individual patient care. Interventions should be based on patient presentation and the clinical judgment of the treating physician. Please refer to product labeling for complete safety information, including dose modification guidelines for adverse reactions.

General Considerations for Monitoring

  • Patients were clinically monitored at regular intervals during the infusion of amivantamab, including an assessment prior to the start of infusion.14
  • Particularly with the initial dose (cycle 1 day 1 and day 2 in case of split dose), patients were monitored closely for early signs and symptoms indicative of an acute IRR.14
  • If clinically indicated, even with mild symptoms, infusion was immediately interrupted to prevent the occurrence of a more serious grade of IRR.14
  • Trained clinical personnel were prepared to intervene in case of IRRs. Resources necessary for resuscitation (ie, agents such as epinephrine, aerosolized bronchodilator, IV antihistamines, IV corticosteroids; medical equipment such as oxygen, airway management equipment including suction, and a defibrillator) were readily available.14

Prevention of IRRs: Predose Medications

  • Required predose medications (glucocorticoid, antihistamine, and antipyretic), and optional medications were administered as described in the tables below.14

Required Predose Medications for RYBREVANT FASPRO or RYBREVANT (All Arms)14,a,b
Medication
Dose
Route
Approximate Dosing Window Before Amivantamab Administration
Cycle/Day
Glucocorticoid
Dexamethasone (10 mg) or methylprednisolone (40 mg) or equivalent
IV
45-60 mins
C1D1
C1D2
(RYBREVANT only)
Oral
At least 60 mins
Antihistamine
Diphenhydramine (25-50 mg) or chlorphenamine (10 mg) or equivalent
IV
15-30 mins
All
Diphenhydramine (25-50 mg) or equivalent
Oral
30-60 mins
Antipyretic
Paracetamol (acetaminophen 650-1000 mg) or equivalent
IV
15-30 min
All
Oral
30-60 min
Abbreviations: C1D1, cycle 1 day 1; C2D2, cycle 2 day 2; IV, intravenous.aIf a medication noted in this table is not locally available, a similar medication and dose may be substituted and administered per local guidelines.bPatients for whom suggested medications are contraindicated should explore alternative medications with their study physician. If alternative medications are not suitable for the intent above, patients are not required to take the corresponding medication.

Optional Predose Medications for RYBREVANT FASPRO or RYBREVANT (All Arms)14,a,b
Medication
Dose
Route
Approximate Dosing Window Before Amivantamab Administration
Cycle/Day
Glucocorticoidc
Dexamethasone (10 mg) or methylprednisolone (40 mg)
IV
45-60 mins
C1D8 and beyond
Oral
60-90 mins
H2-antagonist
Ranitidine (50 mg) or equivalent
IV
15-30 mins
Any
Antiemetic
Ondansetron (16 mg) or equivalent
IV
15-30 min
Any
Ondansetron (8 mg) or equivalent
Oral
Abbreviations: C1D1, cycle 1 day 1; C2D2, cycle 2 day 2; C1D8, cycle 1 day 8; H2, histamine type 2 receptor; IV, intravenous.aIf a medication noted in this table is not locally available, a similar medication and dose may be substituted and administered per local guidelines.bPatients for whom suggested medications are contraindicated should explore alternative medications with their study physician. If alternative medications are not suitable for the intent above, patients are not required to take the corresponding medication.cBeginning with C1D8, optional predose steroids may be administered prior to amivantamab if clinically indicated for patients who experienced an IRR on C1D1 or C1D2.

Prevention of IRRs: Postdose Medications

Optional postdose medications (mentioned in the below table) were prescribed and continued for up to 48 hours after any dose if clinically indicated, at the discretion of the treating physician.14


Optional Postdose Medications for RYBREVANT FASPRO or RYBREVANT (All Arms)14,a
Medication
Dose
Route
Administration Instructions
Cycle/Day
Glucocorticoid
Dexamethasone (10 mg) or comparable corticosteroid
IV or oral
As clinically indicated
Any
Antihistamine
Diphenhydramine (25-50 mg) or equivalent
IV or oral
As clinically indicated
Any
Antipyretic
Paracetamol (acetaminophen 650-1,000 mg)
IV or oral
As clinically indicated
Any
Opiates
Meperidine (25-100 mg)
IV or oral
As clinically indicated
Any
Antiemetic
Ondansetron (8-16 mg) or equivalent
IV
As clinically indicated
Any
Ondansetron (8 mg) or equivalent
Oral
Abbreviations: IV, intravenous.aOptional medications are used prophylactically as clinically indicated. If a medication noted in this table is not locally available, a similar medication and dose may be substituted and administered per local guidelines.

Treatment of IRRs

  • Patients who experience early symptoms of IRRs, manifesting as fever, chills, rigors, bronchospasm, headache, rash, pruritus, arthralgia, and hypo- or hypertension or other symptoms, should have their infusions interrupted, if indicated, and the symptoms managed as summarized in the table below.14
  • With the initial dose of amivantamab (cycle 1 day 1 for RYBREVANT FASPRO and cycle 1 days 1 and 2 for RYBREVANT), interruption of the infusion should be considered even with mild symptoms to prevent more severe manifestations of IRR.14

Management of Local Administration-Related Reactions (LARRs)

  • LARRs are considered a potential risk of SC administration. The administration of RYBREVANT FASPRO in abdominal SC tissue was associated with LARRs, such as induration and erythema, in some patients.14
  • LARRs should be managed per institutional standards. The prophylactic and reactive management recommendations for LARRs are the same as those of IRRs.14

Management of IRRs14
IRR Gradinga
Treatment/Intervention
Premedication at Subsequent Dosing
Grade 1:
Mild reaction
Monitor patient as medically indicated until recovery from symptoms. If occurring with initial dose (ie, C1D1 or C1D2), consider early infusion interruption to prevent more severe symptoms.
Antihistamine, antipyretic, and glucocorticoid per Table: Required Predose Medications for RYBREVANT FASPRO or RYBREVANT (All Arms)
Grade 2:
Moderate reaction; therapy or infusion interrupted but responds promptly to symptomatic treatment
Interrupt infusion, if ongoing: If clinically indicated, start IV fluids; give diphenhydramine 50 mg (or equivalent) IV and/or paracetamol (acetaminophen) 650-1000 mg; consider corticosteroids, bronchodilator therapy and supplemental oxygen; monitor patient closely until recovery from symptoms.
First interruption for IRR—restart infusion at 50% of the rate at the time of interruption: If no further evidence of IRR after 30 minutes, the rate may be increased to 100% of the infusion rate at the time of interruption; monitor patient closely. Infusion rate escalation may resume after the infusion has been administered for at least 30 minutes at 100% of the infusion rate used at the time of dose interruption.
Second interruption for IRR: Stop and consider discontinuation of further drug treatment at that visit; administer diphenhydramine 50 mg IV or equivalent and monitor patient until resolution of symptoms. If continuing administration after the second interruption, restart infusion at 50% of the rate at the time of the second interruption. If no further evidence of IRR after 30 minutes, the rate may be increased to 100% of the infusion rate at the time of interruption; monitor patient closely. Infusion rate escalation may resume after the infusion has been administered for at least 30 minutes at 100% of the infusion rate used at the time of dose interruption.
Antihistamine, antipyretic, and glucocorticoid per Table: Required Predose Medications for RYBREVANT FASPRO or RYBREVANT (All Arms)
Consider meperidine if patient experiences chills and rigors.
Grade 3/4
Grade 3: severe reaction, prolonged (ie, not rapidly responsive to symptomatic medication and/or brief interruption of infusion); recurrence of symptoms following initial improvement; hospitalization indicated for other clinical sequelae (eg, renal impairment, pulmonary infiltrates)
Grade 4: life-threatening; pressor or ventilator support indicated
Stop infusion, if ongoing: Start IV saline infusion; recommend bronchodilators, supplemental oxygen, epinephrine 0.2-1 mg of a 1:1000 solution for SC administration or 0.1-0.25 mg of a 1:10,000 solution injected slowly for IV administration, and/or diphenhydramine 50 mg IV with methylprednisolone 100 mg IV (or equivalent), as needed (other drugs as appropriate).
Patient should be monitored until the treating physician is comfortable that the symptoms will not recur. Physicians should follow their institutional guidelines for the treatment of anaphylaxis. In the case of late-occurring hypersensitivity symptoms (eg, appearance of a localized or generalized pruritus within 1 week after treatment), symptomatic treatment may be given (eg, oral antihistamine, corticosteroid), as appropriate.
Based on severity of symptoms, consider permanent discontinuation of drug.
Abbreviations: C1D1, cycle 1 day 1; C2D2, cycle 2 day 2; IRR, infusion-related reaction; IV, intravenous; SC, subcutaneous.aPer National Cancer Institute - Common Terminology Criteria for Adverse Events Version 5.0.

Literature Search

A literature search of MEDLINE®, Embase®, BIOSIS Previews®, and DerwentDrug File (and/or other resources, including internal/external databases) was conducted on 10 December 2025. The information included in this response is limited to relevant data from the PALOMA-3 and PALOMA-2 studies.

 

References

Show
1 Leighl NB, Akamatsu H, Lim SM, et al. Subcutaneous versus intravenous amivantamab, both in combination with lazertinib, in refractory epidermal growth factor receptor-mutated non-small cell lung cancer: primary results from the phase III PALOMA-3 study. J Clin Oncol. 2024;42(30):3593-3605.  
2 Moores SL, Chiu ML, Bushey BS, et al. A novel bispecific antibody targeting EGFR and cMet is effective against EGFR inhibitor-resistant lung tumors. Cancer Res. 2016;76(13):3942-3953.  
3 Cho BC, Felip E, Hayashi H, et al. MARIPOSA: phase 3 study of first-line amivantamab + lazertinib versus osimertinib in EGFR-mutant non-small-cell lung cancer. Future Oncol. 2022;18(6):639-647.  
4 Janssen Research & Development, LLC. A phase 3, open-label, randomized study of lazertinib with subcutaneous amivantamab compared with intravenous amivantamab in patients with EGFR-mutated advanced or metastatic non-small cell lung cancer after progression on osimertinib and chemotherapy. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 December 10]. Available from: https://clinicaltrials.gov/study/NCT05388669 NLM Identifier: NCT05388669.  
5 Lim SM, Tan JL, Dias JM, et al. Subcutaneous amivantamab and lazertinib as first-line treatment in patients with EGFR-mutated advanced non-small cell lung cancer (NSCLC): interim results from the phase 2 PALOMA-2 study. Poster presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; May 31-June 4, 2024; Chicago, IL.  
6 Janssen Research & Development, LLC. A phase 2, open-label, parallel cohort study of subcutaneous amivantamab in multiple regimens in patients with advanced or metastatic solid tumors including EGFR-mutated non-small cell lung cancer. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 December 10]. Available from: https://clinicaltrials.gov/study/NCT05498428 NLM Identifier: NCT05498428.  
7 Lim SM, Tan JL, Wang J, et al. First-line subcutaneous amivantamab plus chemotherapy in EGFR Exon 20 insertion-mutated advanced NSCLC: results from PALOMA-2. Oral Presentation presented at: International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer (WCLC); September 6-9, 2025; Barcelona, Spain.  
8 Nadal E, Neal JW, Signorelli D, et al. Subcutaneous amivantamab plus chemotherapy in EGFR-mutant advanced non-small cell lung cancer after disease progression on osimertinib. Poster presented at: European Society for Medical Oncology (ESMO) Congress; October 17-21, 2025; Berlin, Germany.  
9 Lim SM, Han JY, Zhang J, et al. Subcutaneous after intravenous amivantamab in advanced NSCLC: initial results from PALOMA 2. Poster presented at: European Lung Cancer Congress (ELCC); March 26-29, 2025; Paris, France.  
10 Scott SC, Dias JM, Liu B, et al. PALOMA-2: subcutaneous amivantamab administered every 4 weeks plus lazertinib in first-line EGFR-mutated advanced NSCLC. Oral Presentation presented at: International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer (WCLC); September 6-9, 2025; Barcelona, Spain.  
11 Data on File. Amivantamab. Clinical Study Report 61186372NSC3004. Janssen Research & Development, LLC. EDMS-RIM-1232939; 2024.  
12 Data on File. Amivantamab. Table TSFAE01AWP: Summary of Treatment Emergent Adverse Events required for Warning & Precautions; All Treated Analysis Set (Study-61186372NSC3004). Janssen Research & Development, LLC; 2025.  
13 Data on File. Amivantamab. Clinical Study Report 61186372NSC2002. Janssen Research & Development, LLC. EDMS-RIM-1438447; 2025.  
14 Leighl NB, Akamatsu H, Lim SM, et al. Clinical Protocol for: Subcutaneous versus intravenous amivantamab, both in combination with lazertinib, in refractory epidermal growth factor receptor-mutated non-small cell lung cancer: primary results from the phase III PALOMA-3 study. J Clin Oncol. 2024;42(30):3593-3605.