BEERSE, BELGIUM (23 February 2026) - Johnson & Johnson today announced that the European Commission (EC) has approved an extension of the RYBREVANT®▼ (amivantamab) marketing authorisation to include additional subcutaneous (SC) dosing regimens. With this decision, SC amivantamab is now authorised for use across all previously approved intravenous (IV) amivantamab indications, including:6
Every-four-week (Q4W) SC amivantamab dosing regimen:6
· in combination with LAZCLUZE®▼(lazertinib) for first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations
· as monotherapy for adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy
Every-three-week (Q3W) SC amivantamab dosing regimen in combination with carboplatin and pemetrexed for adult patients with advanced NSCLC:6
· with EGFR exon 19 deletions or exon 21 L858R substitution mutations after failure of prior therapy, including an EGFR tyrosine kinase inhibitor (TKI)
· with activating EGFR exon 20 insertion mutations, as first-line treatment
“The approval of additional subcutaneous dosing options represents a step forward in how we can deliver amivantamab in clinical practice for EGFR-mutated non-small cell lung cancer,” said Silvia Novello, M.D., Ph.D., Professor of Medical Oncology in the Oncology Department at San Luigi Hospital in Orbassano, University of Turin, Italy.** “Having the option to transition from every-two-week to every-four-week dosing allows us to better align treatment with individual patient needs. These subcutaneous regimens have demonstrated efficacy and safety consistent with the intravenous formulation, while offering practical advantages like reduced time in clinic, and fewer administration-related reactions, making a real difference for both patients and healthcare teams.”
The approval is supported by results from the Phase 2 PALOMA-2 and Phase 1 PALOMA studies, evaluating the feasibility of SC administration, pharmacokinetics, efficacy and safety of SC amivantamab in multiple regimens in patients with locally advanced or metastatic EGFR-mutated NSCLC, including the Q3W and Q4W dosing regimens.1,2,3,4,5 Results demonstrated that treatment with SC amivantamab resulted in a response rate and safety profile consistent with historical IV amivantamab dosing, but with a significantly reduced incidence of administration-related reactions (ARRs).1,2,3,4,5 Administration time with SC amivantamab was faster, approximately five minutes compared to five hours for the first IV amivantamab infusion.1,2,3,4,5 Consistent with IV amivantamab, the most common treatment-emergent adverse events (TEAEs) were EGFR- and MET-related. These included dermatitis acneiform, paronychia, rash, stomatitis, and hypoalbuminemia.1,2,3,4,5
“The approval of these new subcutaneous dosing regimens marks an important step in Johnson & Johnson’s commitment to transforming the treatment journey for patients with EGFR-mutated non-small cell lung cancer,” said Henar Hevia, Ph.D., Senior Director, EMEA Therapeutic Area Head, Oncology, Johnson & Johnson Innovative Medicine. “By offering more flexible and convenient options, we aim to reduce the burden of treatment on patients and their caregivers across all approved indications, while maintaining the well-established efficacy of intravenous amivantamab. This milestone reflects our broader mission to deliver therapies that not only extend and improve lives but also prioritise the experience of those receiving them.”
About the PALOMA Study
PALOMA (NCT04606381), is an open-label, multicentre, dose escalation Phase 1b study which assessed the feasibility of SC administration of amivantamab based on safety and pharmacokinetics (PK) in patients with advanced solid tumours who may benefit from EGFR-or MET-directed therapy, to determine a dose, dose regimen and formulation for SC amivantamab delivery.1,3,7
About the PALOMA-2 Study
PALOMA-2 (NCT05498428) is an open-label Phase 2 study evaluating the efficacy, safety, and PK of first and second-line SC amivantamab (administered via manual injection) as a monotherapy or combined with lazertinib and/or chemotherapy in patients with EGFR-mutated locally advanced or metastatic NSCLC.2,4,5,8 The primary endpoints are safety and objective response rate (ORR) as assessed by the investigator per RECIST v1.1*.8
About Amivantamab
Amivantamab is a fully-human EGFR-MET bispecific antibody that acts by targeting tumours with activating and resistance EGFR mutations and MET mutations and amplifications, and by harnessing the immune system.6,9,10,11
The European Commission (EC) has previously approved amivantamab in the following indications:6
Intravenous amivantamab:
· In combination with lazertinib for the first-line treatment of adult patients with advanced non–small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations.
· In combination with carboplatin and pemetrexed for the treatment of adult patients with advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations after failure of prior therapy, including an EGFR tyrosine kinase inhibitor (TKI).
· In combination with carboplatin and pemetrexed for the first-line treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations.
· As monotherapy for the treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy.
Subcutaneous amivantamab:
· In combination with lazertinib for the first-line treatment of adult patients with advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations.
· As monotherapy for treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations, after failure of platinum-based therapy.
Subcutaneous (SC) amivantamab is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology.12
For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using amivantamab, please refer to the Summary of Product Characteristics.6
▼ In line with EU regulations for new medicines, amivantamab is subject to additional monitoring.
About Lazertinib
In 2018, Janssen Biotech, Inc. entered into a license and collaboration agreement with Yuhan Corporation for the development of lazertinib. Lazertinib is an oral, third-generation, brain-penetrant EGFR tyrosine kinase inhibitor (TKI) that targets both the T790M mutation and activating EGFR mutations while sparing wild-type EGFR.13 An analysis of the efficacy and safety of lazertinib from the Phase 3 study LASER301 was published in The Journal of Clinical Oncology in 2023.13
In January 2025, the European Commission approved a marketing authorisation for lazertinib, in combination with amivantamab, for the first-line treatment of adult patients with advanced NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutations.14
For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using lazertinib, please refer to the Summary of Product Characteristics.15
▼ In line with EU regulations for new medicines, lazertinib is subject to additional monitoring.
About Non-Small Cell Lung Cancer
In Europe, it is estimated that 484,306 people were diagnosed with lung cancer in 2022.16 NSCLC accounts for 85 percent of all lung cancer cases.17 Lung cancer is Europe’s biggest cancer killer, with more deaths than breast cancer and prostate cancer combined.16
The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma and large cell carcinoma.17Among the most common driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase controlling cell growth and division.17,18 EGFR mutations are present in 10 to 15 percent of Western patients with NSCLC with adenocarcinoma histology and occur in 40 to 50 percent of Asian patients.19,20,21,22 EGFR ex19del or EGFR exon 21 L858R mutations are the most common EGFR mutations.23 The five-year survival rate for all patients with advanced NSCLC and EGFR mutations treated with EGFR TKIs is less than 20 percent and between 25-32 percent of patients receiving the current first-line standard of care, osimertinib, do not survive long enough to reach second-line treatment.24,25,26,27,28,29,30 EGFR exon 20 insertion (ex20ins) mutations are the third most prevalent activating EGFR mutation.31 Patients with EGFR ex20ins mutations have a real-world five-year OS of eight percent in the frontline setting, which is worse than patients with EGFR ex19del or L858R mutations, who have a real-world five-year OS of 19 percent.25
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.
Learn more at https://innovativemedicine.jnj.com/emea/. Follow us at https://www.linkedin.com/company/jnj-innovative-medicine-emea/.
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of amivantamab or lazertinib. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at http://www.sec.gov/, http://www.jnj.com/ or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.
Footnotes:
**Prof. Novello has served as a consultant to Johnson & Johnson; she has not been paid for any media work.
*RECIST (v1.1) refers to Response Evaluation Criteria in Solid Tumors, which is a standard way to measure how well solid tumours respond to treatment and is based on whether tumours shrink, stay the same or get bigger.
1 Minchom AR, et al. Subcutaneous amivantamab (ami) in patients (pts) with advanced solid malignancies: The PALOMA study-Updated safety and identification of the recommended phase 2 dose. ESMO Poster. 2023.
2 Lim S, et al. Subcutaneous amivantamab and lazertinib as first-line treatment in patients with advanced EGFR-mutated, non-small cell lung cancer (NSCLC): Interim results from the phase 2 PALOMA-2 study. 2024 American Society for Clinical Oncology Annual Meeting. June 3, 2024.
3 Leighl NB, Minchom AR, Lee KH, et al. Subcutaneous amivantamab administered every 4 weeks (Q4W) in patients with advanced solid malignancies: the phase 1b PALOMA study. Oral Presentation presented at: European Lung Cancer Congress (ELCC); March 20-23, 2024; Prague, Czech Republic.
4 Scott C, et al. PALOMA-2: Subcutaneous Amivantamab Administered Every 4 Weeks Plus Lazertinib in First-Line EGFR-Mutated Advanced NSCLC. Poster Presented at IASLC 2025 World Conference on Lung Cancer.
5 Lim S, et al. First-Line Subcutaneous Amivantamab Plus Chemotherapy in EGFR Exon 20 Insertion-Mutated Advanced NSCLC: Results From PALOMA-2. Poster Presented at IASLC 2025 World Conference on Lung Cancer
6 European Medicines Agency. Amivantamab Summary of Product Characteristics. February 2026.
7 ClinicalTrials.gov. A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies (PALOMA). https://clinicaltrials.gov/study/NCT04606381. Accessed: February 2026.
8 ClinicalTrials.gov. A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer (PALOMA-2). https://clinicaltrials.gov/study/NCT05498428. Accessed: February 2026.
9 Moores SL, et al. A Novel Bispecific Antibody Targeting EGFR and cMet Is Effective against EGFR Inhibitor-Resistant Lung Tumors. Cancer Res 2016;76(13)(suppl 27216193):3942-3953.
10 Grugan KD, et al. Fc-mediated activity of EGFR x c-Met bispecific antibody JNJ-61186372 enhanced killing of lung cancer cells. Mabs. 2017;9(1):114-126.
11 Yun J, et al. Antitumor Activity of Amivantamab (JNJ-61186372), an EGFR–MET Bispecific Antibody, in Diverse Models of EGFR Exon 20 Insertion–Driven NSCLC. Cancer Discov. 2020;10(8):1194-1209.
12 Leighl NB 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. ASCO Journal of Clinical Oncology. 2024;42(3):3593-3605.
13 Cho, BC, et al. Lazertinib versus gefitinib as first-line treatment in patients with EGFR-mutated advanced non-small-cell lung cancer: Results From LASER301. J Clin Oncol. 2023;41(26):4208-4217.
14 Innovativemedicine.jnj.com/EMEA. European Commission approves LAZCLUZE®▼ (lazertinib) in combination with RYBREVANT®▼ (amivantamab) for the first-line treatment of patients with EGFR-mutated advanced non-small cell lung cancer. Available at: https://www.jnj.com/media-center/press-releases/european-commission-approves-lazcluze-lazertinib-in-combination-with-rybrevant-amivantamab-for-the-first-line-treatment-of-patients-with-egfr-mutated-advanced-non-small-cell-lung-cancer. Accessed: February 2026.
15 European Medicines Agency. Lazcluze. January 2025. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/lazcluze. Accessed: February 2026.
16 Global Cancer Observatory. Cancer Today. Available at: https://gco.iarc.who.int/media/globocan/factsheets/populations/908-europe-fact-sheet.pdf. Accessed: February 2026
17 Zappa C, et al. Non-small cell lung cancer: current treatment and future advances. Transl Lung Cancer Res. 2016;5(3):288–300.
18 Wee P & Wang Z. Epidermal Growth Factor Receptor Cell Proliferation Signaling Pathways. Cancers. 2017;9(12):52.
19 Pennell NA, et al. A phase II trial of adjuvant erlotinib in patients with resected epidermal growth factor receptor-mutant non-small cell lung cancer. J Clin Oncol. 2019;37(2):97-104.
20 Burnett H, et al. Epidemiological and clinical burden of EGFR exon 20 insertion in advanced non-small cell lung cancer: a systematic literature review. Abstract presented at: World Conference on Lung Cancer Annual Meeting (Singapore); January 29, 2021.
21 Zhang YL, et al. The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis. Oncotarget. 2016;7(48):78985- 78993.
22 Midha A, et al. EGFR mutation incidence in non-small-cell lung cancer of adenocarcinoma histology: a systematic review and global map by ethnicity. Am J Cancer Res. 2015;5(9):2892-2911.
23 American Lung Association. EGFR and Lung Cancer. Available at: https://www.lung.org/lung-health-diseases/lung-disease-lookup/lung-cancer/symptoms-diagnosis/biomarker-testing/egfr. Accessed: February 2026.
24 Lin JJ, et al. Five-Year Survival in EGFR-Mutant Metastatic Lung Adenocarcinoma Treated with EGFR-TKIs. J Thorac Oncol 2016 Apr;11(4):556-65.
25 Girard N, et al. Comparative clinical outcomes for patients with NSCLC harboring EGFR exon 20 insertion mutations and common EGFR mutations. Abstract presented at: World Conference on Lung Cancer Annual Meeting; January 29, 2021; Singapore.
26 Shao J et al. The number of brain metastases predicts the survival of non-small cell lung cancer patients with EGFRR mutation status. Cancer Rep (Hoboken). 2022;5(9): e1550.
27 Achrol A et al. Brain metastases. Nat Rev Dis Primers. 2019;17(5): 5.
28 Rangachari D et al. Brain metastases in patients with EGFR-mutated or ALK-rearranged non-small-cell lung cancers. Lung Cancer. 2015;88(1): 108-111.
29 Nieva J, et al. A real-world (rw) observational study of long-term survival (LTS) and treatment patterns after first-line (1L) osimertinib in patients (pts) with epidermal growth factor receptor (EGFR) mutation-positive (m) advanced non-small cell lung cancer (NSCLC). Ann Oncol. 2023;34, S774.
30 Girard N, Leighl NB, Ohe Y, et al. Mortality among EGFR-mutated advanced NSCLC patients after starting frontline osimertinib treatment: a real-world, US attrition analysis. Presented at: the European Lung Cancer Congress; March 29-April 1, 2023; Copenhagen, Denmark. Poster 19P.
31 Arcila, M. et al. EGFR exon 20 insertion mutations in lung adenocarcinomas: prevalence, molecular heterogeneity, and clinicopathologic characteristics. Mol Cancer Ther. 2013 Feb; 12(2):220-9.
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