FDA approves RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) as the only EGFR-targeted therapy that can be administered once a month

NEWS RELEASE FDA approves RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) as the only EGFR-targeted therapy that can be administered once a month 2026-02-17 Monthly dosing reduces treatment visits while maintaining established safety and ecacy Builds on RYBREVANT FASPRO™ FDA approval to deliver the simplest and fastest combination regimen for EGFR+ non-small cell lung cancer HORSHAM, Pa., Feb. 17, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced the U.S. Food and Drug Administration (FDA) has approved a new, simplied monthly dosing schedule* for RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj). When administered in combination with oral LAZCLUZE (lazertinib) for the rst-line treatment of epidermal growth factor receptor (EGFR)-mutated advanced non-small cell lung cancer (NSCLC), monthly dosing delivers consistent outcomes with the previously approved bi-weekly subcutaneous (SC) dosing schedule. This milestone builds upon the recent FDA approval of RYBREVANT FASPRO™, which transformed administration time from hours to minutes and oers a vefold reduction in administration-related reactions (ARRs), when compared to intravenous (IV) delivery. With this newly approved monthly dosing schedule, patients are able to transition to monthly dosing as early as Week 5. Together, these advances build on an unmatched survival benet while supporting continued treatment optimization, further simplifying care delivery and oering greater convenience. "A monthly dosing schedule oers patients convenience without sacricing ecacy," said Danny Nguyen, M.D., Assistant Clinical Professor, Department of Medical Oncology & Therapeutics Research, City of Hope, and principal 1,2 1,3-6 ® 1,2 1 1 investigator for the PALOMA-3 and MARIPOSA studies.** "With a exible schedule that reduces time in the clinic, patients may be able to stay on therapy longer and free up time to focus on the moments that matter most." Recently presented at the 2025 World Conference on Lung Cancer (WCLC), PALOMA-2 data demonstrated that monthly RYBREVANT FASPRO™ dosing in combination with LAZCLUZE delivered a high objective response rate (ORR) in previously untreated, EGFR-mutated advanced NSCLC. The study showed signicant reduction in ARRs compared to historical IV administration and consistent rates with bi-weekly SC delivery. "This latest milestone represents the culmination of our unwavering eorts and commitment to fundamentally redene the way we treat patients with EGFR-mutated non-small cell lung cancer," said Mahadi Baig, M.D., M.H.C.M., Vice President, U.S. Medical Aairs, Johnson & Johnson. "Building on unmatched overall survival and regimens that support proactive side eect management, this once-monthly injection now delivers the simplest and fastest combination therapy for patients with EGFR-mutated non-small cell lung cancer." The safety prole of monthly dosing of RYBREVANT FASPRO™ is comparable when it is administered every two weeks. Consistent with IV and SC administration, most adverse events were related to EGFR/MET inhibition. ARRs were consistent with the bi-weekly dosing schedule (12% vs 13% respectively) and vefold lower when compared to historical IV administration (66%). Similarly, venous thromboembolic events (VTEs) were consistent with bi-weekly SC administration (13% vs 11% with anticoagulation) and lower than historic IV data without anticoagulation (38%). No new safety signals were identied. Only 8% of patients discontinued amivantamab due to treatment-related adverse events. The mean plasma concentration levels were consistent with historical IV and bi-weekly SC dosing data, supporting pharmacokinetic comparability. Access to RYBREVANT FASPRO™ Johnson & Johnson oers comprehensive access and support information and resources to assist patients in gaining access to RYBREVANT FASPRO™. Our patient support program, RYBREVANT withMe, is available to provide personalized support to help patients start and stay on their Johnson & Johnson medicines. RYBREVANT withMe helps providers support their patients by verifying patients' insurance coverage, providing information on Prior Authorization and Appeals processes and educating on reimbursement processes. Patients can connect to RYBREVANT withMe to receive cost support, regardless of insurance type, free, personalized one-on-one support from a Care Navigator, and resources and community connections. Learn more at RYBREVANTwithMe.com or by calling 833-JNJ-wMe1 (833-565-9631). About the PALOMA-2 Study PALOMA-2 (NCT05498428) is an open-label Phase 2 study evaluating the ecacy, safety, and pharmacokinetics (PK) ® 2 1,2 2 † 2 of rst-line SC amivantamab (administered via manual injection) combined with LAZCLUZE and/or chemotherapy in patients with EGFR-mutated advanced or metastatic NSCLC. The primary endpoint was ORR as assessed by the investigator per RECIST v1.1. PALOMA-2 Cohort 5 evaluated the ecacy, PK, and safety of rst-line SC amivantamab Q4W plus LAZCLUZE in EGFR-mutated NSCLC. About the MARIPOSA Study MARIPOSA (NCT04487080), which enrolled 1,074 patients, is a randomized, Phase 3 study evaluating RYBREVANT (amivantamab-vmjw) plus LAZCLUZE versus osimertinib and versus LAZCLUZE alone in rst-line treatment of patients with locally advanced or metastatic NSCLC with EGFR ex19del or substitution mutations. The primary endpoint of the study is PFS (using RECIST v1.1 guidelines) as assessed by Blinded Independent Central Review (BICR). Secondary endpoints include overall survival (OS), ORR, duration of response (DoR), progression-free survival after rst subsequent therapy (PFS2) and intracranial PFS. Resistance to third-generation tyrosine kinase inhibitors (TKIs), such as osimertinib (when given alone or with chemotherapy), remains a major barrier to long-term disease control. The combination regimen RYBREVANT plus LAZCLUZE uses a multitargeted mechanism of action: targeting EGFR mutations from two angles, blocking MET, and engaging the immune system. This approach has the potential to change the natural history of the disease by reducing the spectrum and complexity of acquired resistance mechanisms. An analysis from MARIPOSA, presented at the International Association for the Study of Lung Cancer (IASLC) 2025 World Congress on Lung Cancer (WCLC), demonstrated that the combination signicantly reduced the development of EGFR- and MET-driven resistance compared with osimertinib in the rst-line setting. MET amplications occurred in three percent of patients on the combination vs 13 percent on osimertinib (P=0.002), and secondary EGFR mutations (such as C797S) were signicantly lower for RYBREVANT plus LAZCLUZE (1 percent vs 8 percent; P=0.01). Notably, acquired MET amplication led to early discontinuation in 23 percent of patients on osimertinib within six months, compared with four percent on RYBREVANT plus LAZCLUZE. About RYBREVANT FASPRO™ and RYBREVANT In December 2025, the U.S. FDA approved RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) across all indications of intravenous RYBREVANT(amivantamab-vmjw). This subcutaneously administered therapy is also approved in Europe, Japan, China, and other markets. RYBREVANT FASPRO™ is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE drug delivery technology. The eectiveness of RYBREVANT FASPRO™ has been established based on adequate and well controlled studies of RYBREVANT. Data across multiple Phase 3 studies, including MARIPOSA, have demonstrated the clinical benet of ® 2,7 ® ® ® ® 8 9 ® ® 10 11  ® ® ® ®12,13 ® ® ® ® 3 RYBREVANT in improving PFS and OS in advanced EGFR-mutated NSCLC. RYBREVANT is approved in the U.S., Europe and other markets across four indications in EGFR-mutated NSCLC, including two in the rst-line setting and two in the second-line, for patients with either exon 19 deletions, exon 21 L858R mutations, or exon 20 insertion mutations, as monotherapy or in combination with LAZCLUZE (lazertinib) or chemotherapy. RYBREVANT is a rst-in-class, fully-human bispecic antibody targeting EGFR and MET with immune cell-directing activity. The National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) include amivantamab-vmjw (RYBREVANT) across multiple treatment settings, including its recent inclusion as a NCCN Category 1 preferred option when used with lazertinib (LAZCLUZE) for rst-line treatment of people with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations. Amivantamab and hyaluronidase-lpuj subcutaneous injection (RYBREVANT FASPRO™) may be substituted for IV amivantamab-vmjw (RYBREVANT). See the latest NCCN Guidelines for NSCLC for complete information. The NCCN Guidelines for Central Nervous System Cancers also identify amivantamab-vmjw (RYBREVANT)-based regimens, including the combination with lazertinib (LAZCLUZE), as the only NCCN-preferred combination options for patients with EGFR-mutated NSCLC and brain metastases. The legal manufacturer for RYBREVANTis Janssen Biotech, Inc. For more information, visit www.RYBREVANT.com. About LAZCLUZE In 2018, Janssen Biotech, Inc., entered into a license and collaboration agreement with Yuhan Corporation for the development of LAZCLUZE (marketed as LECLAZA in South Korea). LAZCLUZE is an oral, third-generation, brain- penetrant EGFR TKI that targets both the T790M mutation and activating EGFR mutations while sparing wild-type EGFR. An analysis of the ecacy and safety of LAZCLUZE from the Phase 3 LASER301 study was published in The Journal of Clinical Oncology in 2023. About Non-Small Cell Lung Cancer (NSCLC) Worldwide, lung cancer is one of the most common cancers, with NSCLC making up 80 to 85 percent of all lung cancer cases. The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma and large cell carcinoma.Among the most common driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase controlling cell growth and division.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.EGFR exon 19 deletions or EGFR L858R mutations are the most common EGFR mutations.The ve-year survival rate for all ® ® ® ® ® ® ®‡ i ® ® ® ® § ǁ ® ® § ǁ ® ® ® ® ® 14,15 15 16 16-19 20,21 4 people with advanced NSCLC and EGFR mutations treated with EGFR TKIs is less than 20 percent.EGFR exon 20 insertion mutations are the third most prevalent activating EGFR mutation.Patients with EGFR exon 20 insertion mutations have a real-world ve-year OS of eight percent in the frontline setting, which is worse than patients with EGFR exon 19 deletions or L858R mutations, who have a real-world ve-year OS of 19 percent. About EGFR Mutations Epidermal growth factor receptor (EGFR) mutations are among the most common oncogenic drivers in NSCLC, especially in younger individuals and those who have never smoked. These mutations promote uncontrolled cell growth and are linked to poor outcomes.Despite progress with targeted therapies, including third-generation EGFR TKI, long-term survival remains limited, with ve-year survival rates below 20 percent.Overcoming resistance mechanisms, such as MET amplication and secondary EGFR mutations, is essential for improving outcomes and extending survival in EGFR-mutated NSCLC. INDICATIONS RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) and RYBREVANT (amivantamab-vmjw) are indicated: in combination with LAZCLUZE (lazertinib) for the rst-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test. in combination with carboplatin and pemetrexed for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor. in combination with carboplatin and pemetrexed for the rst-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test. as a single agent for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA approved test, whose disease has progressed on or after platinum-based chemotherapy. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS RYBREVANT FASPRO™ is contraindicated in patients with known hypersensitivity to hyaluronidase or to any of its 22 23 21 19 22 12 ® ® 1 5 excipients. WARNINGS AND PRECAUTIONS Hypersensitivity and Administration-Related Reactions with RYBREVANT FASPRO™  RYBREVANT FASPRO™ can cause hypersensitivity and administration-related reactions (ARRs); signs and symptoms of ARR include dyspnea, ushing, fever, chills, chest discomfort, hypotension, and vomiting. The median time to ARR onset is approximately 2 hours. RYBREVANT FASPRO™ with LAZCLUZE In PALOMA-3 (n=206), all Grade ARRs occurred in 13% of patients, including 0.5% Grade 3. Of the patients who experienced ARRs, 89% occurred with the initial dose (Week 1, Day 1). Premedicate with antihistamines, antipyretics, and glucocorticoids and administer RYBREVANT FASPRO™ as recommended. Monitor patients for any signs and symptoms of administration-related reactions during injection in a setting where cardiopulmonary resuscitation medication and equipment are available. Interrupt RYBREVANT FASPRO™ injection if ARR is suspected. Resume treatment upon resolution of symptoms or permanently discontinue RYBREVANT FASPRO™ based on severity. Infusion-Related Reactions with RYBREVANT RYBREVANT can cause infusion-related reactions (IRR) including anaphylaxis; signs and symptoms of IRR include dyspnea, ushing, fever, chills, nausea, chest discomfort, hypotension, and vomiting. The median time to IRR onset is approximately 1 hour. RYBREVANT with LAZCLUZE In MARIPOSA (n=421), IRRs occurred in 63% of patients, including Grade 3 in 5% and Grade 4 in 1% of patients. IRR- related infusion modications occurred in 54%, dose reduction in 0.7%, and permanent discontinuation of RYBREVANT in 4.5% of patients. RYBREVANT with Carboplatin and Pemetrexed Based on the pooled safety population (n=281), IRRs occurred in 50% of patients including Grade 3 (3.2%) adverse reactions. IRR-related infusion modications occurred in 46%, and permanent discontinuation of RYBREVANT in 2.8% of patients. ® ® ® ® ® ® ® ® 6 RYBREVANT as a Single Agent In CHRYSALIS (n=302), IRRs occurred in 66% of patients. IRRs occurred in 65% of patients on Week 1 Day 1, 3.4% on Day 2 infusion, 0.4% with Week 2 infusion, and were cumulatively 1.1% with subsequent infusions. 97% were Grade 1-2, 2.2% were Grade 3, and 0.4% were Grade 4. The median time to onset was 1 hour (range: 0.1 to 18 hours) after start of infusion. IRR-related infusion modications occurred in 62%, and permanent discontinuation of RYBREVANT in 1.3% of patients. Premedicate with antihistamines, antipyretics, and glucocorticoids and infuse RYBREVANT as recommended. Administer RYBREVANT via a peripheral line on Week 1 and Week 2 to reduce the risk of IRRs. Monitor patients for signs and symptoms of IRRs in a setting where cardiopulmonary resuscitation medication and equipment are available. Interrupt infusion if IRR is suspected. Reduce the infusion rate or permanently discontinue RYBREVANT based on severity. If an anaphylactic reaction occurs, permanently discontinue RYBREVANT. Interstitial Lung Disease/Pneumonitis RYBREVANT FASPRO™ and RYBREVANT can cause severe and fatal interstitial lung disease (ILD)/pneumonitis. RYBREVANT FASPRO™ with LAZCLUZE In PALOMA-3, ILD/pneumonitis occurred in 6% of patients, including Grade 3 in 1%, Grade 4 in 1.5%, and fatal cases in 1.9% of patients. 5% of patients permanently discontinued RYBREVANT FASPRO™ and LAZCLUZE due to ILD/pneumonitis. RYBREVANT with LAZCLUZE In MARIPOSA, ILD/pneumonitis occurred in 3.1% of patients, including Grade 3 in 1.0% and Grade 4 in 0.2% of patients. There was one fatal case of ILD/pneumonitis and 2.9% of patients permanently discontinued RYBREVANT and LAZCLUZE due to ILD/pneumonitis. RYBREVANT with Carboplatin and Pemetrexed Based on the pooled safety population, ILD/pneumonitis occurred in 2.1% of patients with 1.8% of patients experiencing Grade 3 ILD/pneumonitis. 2.1% discontinued RYBREVANT due to ILD/pneumonitis. RYBREVANT as a Single Agent ® ® ® ® ® ® ® ® ® ® ® ® ® ® ® ® 7 In CHRYSALIS, ILD/pneumonitis occurred in 3.3% of patients, with 0.7% of patients experiencing Grade 3 ILD/pneumonitis. Three patients (1%) permanently discontinued RYBREVANT due to ILD/pneumonitis. Monitor patients for new or worsening symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold RYBREVANT FASPRO™ or RYBREVANT and LAZCLUZE (when applicable) in patients with suspected ILD/pneumonitis and permanently discontinue if ILD/pneumonitis is conrmed. Venous Thromboembolic (VTE) Events with Concomitant Use with LAZCLUZE RYBREVANT FASPRO™ and RYBREVANT in combination with LAZCLUZE can cause serious and fatal venous thromboembolic (VTE) events, including deep vein thrombosis and pulmonary embolism. Without prophylactic anticoagulation, the majority of these events occurred during the rst four months of treatment. RYBREVANT FASPRO™ with LAZCLUZE In PALOMA-3 (n=206), all Grade VTE occurred in 11% of patients and 1.5% were Grade 3. 80% (n=164) of patients received prophylactic anticoagulation at study entry, with an all Grade VTE incidence of 7%. In patients who did not receive prophylactic anticoagulation (n=42), all Grade VTE occurred in 17% of patients. In total, 0.5% of patients had VTE leading to dose reductions of RYBREVANT FASPRO™ and no patients required permanent discontinuation. The median time to onset of VTEs was 95 days (range: 17 to 390). RYBREVANT with LAZCLUZE In MARIPOSA, VTEs occurred in 36% of patients including Grade 3 in 10% and Grade 4 in 0.5% of patients. On-study VTEs occurred in 1.2% of patients (n=5) while receiving anticoagulation therapy. There were two fatal cases of VTE (0.5%), 9% of patients had VTE leading to dose interruptions of RYBREVANT, and 7% of patients had VTE leading to dose interruptions of LAZCLUZE; 1% of patients had VTE leading to dose reductions of RYBREVANT, and 0.5% of patients had VTE leading to dose reductions of LAZCLUZE; 3.1% of patients had VTE leading to permanent discontinuation of RYBREVANT, and 1.9% of patients had VTE leading to permanent discontinuation of LAZCLUZE. The median time to onset of VTEs was 84 days (range: 6 to 777). Administer prophylactic anticoagulation for the rst four months of treatment. The use of Vitamin K antagonists is not recommended. Monitor for signs and symptoms of VTE events and treat as medically appropriate. Withhold RYBREVANT FASPRO™ or RYBREVANT and LAZCLUZE based on severity. Once anticoagulant treatment has been initiated, resume RYBREVANT FASPRO™ or RYBREVANT and LAZCLUZE at the same dose level at the discretion of the ® ® ® ® ® ® ® ® ® ® ® ® ® ® ® ® ® ® ® 8 healthcare provider. In the event of VTE recurrence despite therapeutic anticoagulation, permanently discontinue RYBREVANT FASPRO™ or RYBREVANT. Treatment can continue with LAZCLUZE at the same dose level at the discretion of the healthcare provider. Refer to the LAZCLUZE Prescribing Information for recommended LAZCLUZE dosage modication. Dermatologic Adverse Reactions RYBREVANT FASPRO™ and RYBREVANT can cause severe rash including toxic epidermal necrolysis (TEN), dermatitis acneiform, pruritus and dry skin. RYBREVANT FASPRO™ with LAZCLUZE In PALOMA-3, rash occurred in 80% of patients, including Grade 3 in 17% and Grade 4 in 0.5% of patients. Rash leading to dose reduction occurred in 11% of patients, and RYBREVANT FASPRO™ was permanently discontinued due to rash in 1.5% of patients. RYBREVANT with LAZCLUZE In MARIPOSA, rash occurred in 86% of patients, including Grade 3 in 26% of patients. The median time to onset of rash was 14 days (range: 1 to 556 days). Rash leading to dose interruptions occurred in 37% of patients for RYBREVANT and 30% for LAZCLUZE, rash leading to dose reductions occurred in 23% of patients for RYBREVANT and 19% for LAZCLUZE, and rash leading to permanent discontinuation occurred in 5% of patients for RYBREVANT and 1.7% for LAZCLUZE. RYBREVANT with Carboplatin and Pemetrexed Based on the pooled safety population, rash occurred in 82% of patients, including Grade 3 (15%) adverse reactions. Rash leading to dose reductions occurred in 14% of patients, and 2.5% permanently discontinued RYBREVANT and 3.1% discontinued pemetrexed. RYBREVANT as a Single Agent In CHRYSALIS, rash occurred in 74% of patients, including Grade 3 in 3.3% of patients. The median time to onset of rash was 14 days (range: 1 to 276 days). Rash leading to dose reduction occurred in 5% and permanent discontinuation due to rash occurred in 0.7% of patients. Toxic epidermal necrolysis occurred in one patient (0.3%). When initiating treatment with RYBREVANT FASPRO™ or RYBREVANT, prophylactic and concomitant medications are recommended to reduce the risk and severity of dermatologic adverse reactions. Instruct patients to limit sun ® ® ® ® ® ® ® ® ® ® ® ® ® ® ® ® ® ® 9 exposure during and for 2 months after treatment. Advise patients to wear protective clothing and use broad spectrum UVA/UVB sunscreen. If skin reactions develop, administer supportive care including topical corticosteroids and topical and/or oral antibiotics. For Grade 3 reactions, add oral steroids and consider dermatologic consultation. Promptly refer patients presenting with severe rash, atypical appearance or distribution, or lack of improvement within 2 weeks to a dermatologist. For patients receiving RYBREVANT FASPRO™ or RYBREVANT in combination with LAZCLUZE, withhold, reduce the dose, or permanently discontinue both drugs based on severity. For patients receiving RYBREVANT FASPRO™ or RYBREVANT as a single agent or in combination with carboplatin and pemetrexed, withhold, dose reduce or permanently discontinue RYBREVANT FASPRO™ or RYBREVANT based on severity. Ocular Toxicity RYBREVANT FASPRO™ and RYBREVANT can cause ocular toxicity including keratitis, blepharitis, dry eye symptoms, conjunctival redness, blurred vision, visual impairment, ocular itching, eye pruritus and uveitis. RYBREVANT FASPRO™ with LAZCLUZE In PALOMA-3, all Grade ocular toxicity occurred in 13% of patients, including 0.5% Grade 3. RYBREVANT with LAZCLUZE In MARIPOSA, ocular toxicity occurred in 16%, including Grade 3 or 4 ocular toxicity in 0.7% of patients. Withhold, reduce the dose, or permanently discontinue RYBREVANT and continue LAZCLUZE based on severity. RYBREVANT with Carboplatin and Pemetrexed Based on the pooled safety population, ocular toxicity occurred in 16% of patients. All events were Grade 1 or 2. RYBREVANT as a Single Agent In CHRYSALIS, keratitis occurred in 0.7% and uveitis occurred in 0.3% of patients. All events were Grade 1-2. Promptly refer patients presenting with new or worsening eye symptoms to an ophthalmologist. Withhold, dose reduce or permanently discontinue RYBREVANT FASPRO™ or RYBREVANT based on severity. Embryo-Fetal Toxicity ® ® ® ® ® ® ® ® ® ® ® ® ® 10 Based on animal models, RYBREVANT FASPRO™, RYBREVANT and LAZCLUZE can cause fetal harm when administered to a pregnant woman. Verify pregnancy status of females of reproductive potential prior to initiating RYBREVANT FASPRO™ and RYBREVANT. Advise pregnant women and females of reproductive potential of the potential risk to the fetus. Advise patients of reproductive potential to use eective contraception during treatment and for 3 months after the last dose of RYBREVANT FASPRO™ or RYBREVANT, and for 3 weeks after the last dose of LAZCLUZE. ADVERSE REACTIONS RYBREVANT FASPRO™ with LAZCLUZE In PALOMA-3 (n=206), the most common adverse reactions ( ≥ 20%) were rash (80%), nail toxicity (58%), musculoskeletal pain (50%), fatigue (37%), stomatitis (36%), edema (34%), nausea (30%), diarrhea (22%), vomiting (22%), constipation (22%), decreased appetite (22%), and headache (21%). The most common Grade 3 or 4 laboratory abnormalities ( ≥ 2%) were decreased lymphocyte count (6%), decreased sodium (5%), decreased potassium (5%), decreased albumin (4.9%), increased alanine aminotransferase (3.4%), decreased platelet count (2.4%), increased aspartate aminotransferase (2%), increased gamma-glutamyl transferase (2%), and decreased hemoglobin (2%). Serious adverse reactions occurred in 33% of patients, with those occurring in ≥ 2% of patients including ILD/pneumonitis (6%); and pneumonia, VTE and fatigue (2.4% each). Death due to adverse reactions occurred in 5% of patients treated with RYBREVANT FASPRO™, including ILD/pneumonitis (1.9%), pneumonia (1.5%), and respiratory failure and sudden death (1% each). RYBREVANT with LAZCLUZE In MARIPOSA (n=421), the most common adverse reactions (ARs) ( ≥ 20%) were rash (86%), nail toxicity (71%), infusion-related reactions (IRRs) (RYBREVANT) (63%), musculoskeletal pain (47%), stomatitis (43%), edema (43%), VTE (36%), paresthesia (35%), fatigue (32%), diarrhea (31%), constipation (29%), COVID-19 (26%), hemorrhage (25%), dry skin (25%), decreased appetite (24%), pruritus (24%), and nausea (21%). The most common Grade 3 or 4 laboratory abnormalities ( ≥ 2%) were decreased albumin (8%), decreased sodium (7%), increased ALT (7%), decreased potassium (5%), decreased hemoglobin (3.8%), increased AST (3.8%), increased GGT (2.6%), and increased magnesium (2.6%). Serious ARs occurred in 49% of patients, with those occurring in ≥ 2% of patients including VTE (11%), pneumonia (4%), ILD/pneumonitis and rash (2.9% each), COVID-19 (2.4%), and pleural eusion and IRRs (RYBREVANT) (2.1% each). Fatal ARs occurred in 7% of patients due to death not otherwise specied (1.2%); sepsis and respiratory ® ® ® ® ® ® ® ® ® ® 11 failure (1% each); pneumonia, myocardial infarction, and sudden death (0.7% each); cerebral infarction, pulmonary embolism (PE), and COVID-19 infection (0.5% each); and ILD/pneumonitis, acute respiratory distress syndrome (ARDS), and cardiopulmonary arrest (0.2% each). RYBREVANT with Carboplatin and Pemetrexed In MARIPOSA-2 (n=130), the most common ARs ( ≥ 20%) were rash (72%), IRRs (59%), fatigue (51%), nail toxicity (45%), nausea (45%), constipation (39%), edema (36%), stomatitis (35%), decreased appetite (31%), musculoskeletal pain (30%), vomiting (25%), and COVID-19 (21%). The most common Grade 3 to 4 laboratory abnormalities ( ≥ 2%) were decreased neutrophils (49%), decreased white blood cells (42%), decreased lymphocytes (28%), decreased platelets (17%), decreased hemoglobin (12%), decreased potassium (11%), decreased sodium (11%), increased alanine aminotransferase (3.9%), decreased albumin (3.8%), and increased gamma-glutamyl transferase (3.1%). In MARIPOSA-2, serious ARs occurred in 32% of patients, with those occurring in >2% of patients including dyspnea (3.1%), thrombocytopenia (3.1%), sepsis (2.3%), and PE (2.3%). Fatal ARs occurred in 2.3% of patients; these included respiratory failure, sepsis, and ventricular brillation (0.8% each). In PAPILLON (n=151), the most common ARs ( ≥ 20%) were rash (90%), nail toxicity (62%), stomatitis (43%), IRRs (42%), fatigue (42%), edema (40%), constipation (40%), decreased appetite (36%), nausea (36%), COVID-19 (24%), diarrhea (21%), and vomiting (21%). The most common Grade 3 to 4 laboratory abnormalities ( ≥ 2%) were decreased albumin (7%), increased alanine aminotransferase (4%), increased gamma-glutamyl transferase (4%), decreased sodium (7%), decreased potassium (11%), decreased magnesium (2%), and decreases in white blood cells (17%), hemoglobin (11%), neutrophils (36%), platelets (10%), and lymphocytes (11%). In PAPILLON, serious ARs occurred in 37% of patients, with those occurring in ≥ 2% of patients including rash, pneumonia, ILD, PE, vomiting, and COVID-19. Fatal adverse reactions occurred in 7 patients (4.6%) due to pneumonia, cerebrovascular accident, cardio-respiratory arrest, COVID-19, sepsis, and death not otherwise specied. RYBREVANT as a Single Agent In CHRYSALIS (n=129), the most common ARs ( ≥ 20%) were rash (84%), IRR (64%), paronychia (50%), musculoskeletal pain (47%), dyspnea (37%), nausea (36%), fatigue (33%), edema (27%), stomatitis (26%), cough (25%), constipation (23%), and vomiting (22%). The most common Grade 3 to 4 laboratory abnormalities ( ≥ 2%) were decreased lymphocytes (8%), decreased albumin (8%), decreased phosphate (8%), decreased potassium (6%), increased alkaline phosphatase (4.8%), increased glucose (4%), increased gamma-glutamyl transferase (4%), and decreased sodium (4%). ® ® 12 Serious ARs occurred in 30% of patients, with those occurring in ≥ 2% of patients including PE, pneumonitis/ILD, dyspnea, musculoskeletal pain, pneumonia, and muscular weakness. Fatal adverse reactions occurred in 2 patients (1.5%) due to pneumonia and 1 patient (0.8%) due to sudden death. LAZCLUZE DRUG INTERACTIONS Avoid concomitant use of LAZCLUZE with strong and moderate CYP3A4 inducers. Consider an alternate concomitant medication with no potential to induce CYP3A4. Monitor for adverse reactions associated with a CYP3A4 or BCRP substrate where minimal concentration changes may lead to serious adverse reactions, as recommended in the approved product labeling for the CYP3A4 or BCRP substrate. Please see full Prescribing Information for RYBREVANT FASPRO™, RYBREVANT and LAZCLUZE. cp-491009v1 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://www.jnj.com/ or at www.innovativemedicine.jnj.com. Follow us at @JNJInnovMed. Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen Global Services, LLC and Janssen Scientic Aairs, LLC are Johnson & Johnson companies. Cautions Concerning Forward-Looking Statements  This press release contains "forward-looking statements" as dened in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benets and treatment impact of RYBREVANT-based regimens. 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 materialize, 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; ® ® ® ® ® 13 uncertainty of commercial success; manufacturing diculties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product ecacy or safety concerns resulting in product recalls or regulatory action; changes in behavior 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 most recent 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 lings with the Securities and Exchange Commission. Copies of these lings are available online at www.sec.gov, 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.  cp-565762 FOOTNOTES * Once-monthly dosing to begin at week 5 onward. Weekly injections are administered between week 1-4.  Dr. Nguyen has provided consulting, advisory, and speaking services to Johnson & Johnson; he has not been paid for any media work.  The patient support and resources provided by J&J withMe are not intended to provide medical advice, replace a treatment plan from the patient's doctor or nurse, provide case management services, or serve as a reason to prescribe a Johnson & Johnson medicine.  The NCCN content does not constitute medical advice and should not be used in place of seeking professional medical advice, diagnosis or treatment by licensed practitioners. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. See the NCCN Guidelines for detailed recommendations, including other treatment options.  The NCCN Guidelines for NSCLC provide recommendations for certain individual biomarkers that should be tested and recommend testing techniques but do not endorse any specic commercially available biomarker assays or commercial laboratories. References ** † ‡ § ǁ 14 RYBREVANT FASPRO™ Prescribing Information. Horsham, PA: Janssen Biotech, Inc. Scott S, et al. PALOMA-2: Subcutaneous Amivantamab Administered Every 4 Weeks Plus Lazertinib in First-Line EGFR-Mutated Advanced NSCLC. Abstract presented at: International Association for the Study of Lung Cancer at the 2025 World Conference on Lung Cancer (WCLC); September 9, 2025; Barcelona, Spain. George S, et al. Systematic literature review of intravenous versus subcutaneous administration of oncology therapies: A clinical, economic and patient perspective. Cancer Treatment Reviews. 2025 Sep; 139(102974):1-13. Bittner B, et al. Subcutaneous Administration of Biotherapeutics: An Overview of Current Challenges and Opportunities. BioDrugs. 2018 Oct;32(5):425-440. Aguiar-Ibáñez R, et al. Dierences Between Intravenous and Subcutaneous Modes of Administration in Oncology from the Patient, Healthcare Provider, and Healthcare System Perspectives: A Systematic Review. Adv Ther. 2024 Dec;41(12):4396-4417. Epstein R S, et al. Cancer patients' perspectives: A qualitative study of reasons for subcutaneous preference vs intravenous treatment. Abstract presented at: 2025 ASCO Annual Meeting; May 28, 2025; Chicago. 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). Accessed January 2026. https://clinicaltrials.gov/study/NCT05498428 ClinicalTrials.gov. A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (MARIPOSA). Accessed January 2026. https://classic.clinicaltrials.gov/ct2/show/NCT04487080 Hayashi H, et al. Mechanisms of Acquired Resistance to First-Line Amivantamab Plus Lazertinib Vs Osimertinib: Updated Analysis from MARIPOSA [IASLC abstract PT1.03.06]. Presented at: IASLC 2025 World Lung Conference on Lung Cancer; September 6-9, 2025; Barcelona, Spain. Yang J, et al. Amivantamab Plus Lazertinib vs Osimertinib in First-line EGFR-mutant Advanced NSCLC – Final Overall Survival from MARIPOSA [ELCC abstract #40]. Presented at: 2025 European Lung Cancer Congress (ELCC); March 26- 29, 2025; Paris, France. Oxnard GR, Lo PC, Nishino M, et al. Natural history and molecular characteristics of lung cancers harboring EGFR exon 20 insertions. J Thorac Oncol. 2013;8(2):179-184. doi:10.1097/JTO.0b013e3182779d18. Hayashi H, et al. Mechanisms of Acquired Resistance to First-Line Amivantamab Plus Lazertinib Vs Osimertinib: Updated Analysis from MARIPOSA [IASLC abstract PT1.03.06]. Presented at: IASLC 2025 World Lung Conference on Lung Cancer; September 6-9, 2025; Barcelona, Spain. Hayashi H, et al. Mechanisms of Acquired Resistance to First-Line Amivantamab Plus Lazertinib Vs Osimertinib: Updated Analysis from MARIPOSA. Poster presented at: IASLC 2025 World Conference on Lung Cancer (WCLC); September 6-9, 2025; Barcelona, Spain. The World Health Organization. Lung Cancer. Accessed July 2025. https://www.who.int/news-room/fact- sheets/detail/lung-cancer American Cancer Society. What is Lung Cancer? Accessed July 15 2025. https://www.cancer.org/content/cancer/en/cancer/lung-cancer/about/what-is.html Melosky B, et al. Worldwide Prevalence of Epidermal Growth Factor Receptor Mutations in Non-Small Cell Lung Cancer: A Meta-Analysis. Mol Diagn Ther. 2021 Nov 23;26(1):7-18. 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. 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. American Cancer Society. Personalized care for patients with EGFR-mutant nonsmall cell lung cancer: Navigating early to advanced disease management. Accessed November 2025. https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.70024  American Lung Association. EGFR and Lung Cancer. Accessed July 2025. https://www.lung.org/lung-health- diseases/lung-disease-lookup/lung-cancer/symptoms-diagnosis/biomarker-testing 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. 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. 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. ___________________________________ Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Non- Small Cell Lung Cancer V.3.2026 © National Comprehensive Cancer Network, Inc. All rights reserved. To view the most recent and complete version of the guideline, go online to NCCN.org. Accessed February 2026. 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