Amivantamab-VMJM

这款药只有中国先做出来，不是因为中国药企比跨国药企更会做药，而是因为全球最懂 EGFR 这个靶点的一批人，2017 年恰好从阿斯利康的亚洲研发中心独立出来，落户成了中国公司迪哲医药。 迪哲医药办公园区外立面品牌标识 他们抢在跨国巨头前面，攻下了 EGFR 20 号外显子插入突变这个被公认为“难成药”的靶点；而中国的审评、临床和产业链效率，把这份先手兑现成了 2023 年 8 月的全球首个获批。 先把事情说清楚：纽约珠宝商黛比 2023 年底确诊肺癌，2024 年 12 月癌细胞扩散到脑部形成 10 个肿瘤。医生一句话点出了关键——“可惜她不是中国人，不然她可以去中国的药店买药。” 这种药就是舒沃替尼，2023 年 8 月在中国获批，美国 FDA 到 2025 年 7 月才批准，而且获批后迟迟没有商业化供货，儿子马克斯只能专程飞到上海把药带回去。服药 19 个月后，黛比的癌症基本得到控制。 一支“阿斯利康中国队”，成了全球第一个动手的 迪哲医药 2017 年成立，前身是阿斯利康全球四大研发中心之一、也是其唯一的肿瘤转化科学中心——亚洲创新药物和早期研发中心 iMED Asia，约 35% 的管理层与研发人员来自阿斯利康。 迪哲医药科创板实时交易行情界面 创始人张小林原是 iMED Asia 负责人，在阿斯利康任职期间主导或参与过易瑞沙、泰瑞沙等 EGFR 靶点药物的研发。 这层出身很关键。做药不是比谁钱多，而是比谁在一个具体靶点上积累够深，能更早判断出“这条分子路径走得通”。EGFR 20 号外显子插入突变在非小细胞肺癌里约占 EGFR 突变的 10%—12%，传统一、二、三代 EGFR-TKI 对它疗效有限，患者长期只能靠含铂化疗。 全球药企都知道这里有需求，难的是怎么做出一个能覆盖这类突变的高选择性分子。 张小林自己的说法很直接： 国际上多个医药公司，包括大型的跨国公司都试图攻克这个靶点，均没有成功。 也就是说，缺的是判断力加执行力，而不只是意愿：能看出这个靶点可以被分子设计突破，并且真的把分子做出来。迪哲是这批人独立后的首个源头创新产品就押在了这里。 从立项到上市六年，靠的是中国这套配套 舒沃替尼 2020 年获中国药监局突破性疗法认定，2022 年获美国 FDA 突破性疗法认定，2023 年 8 月附条件批准上市，2025 年 7 月获 FDA 加速批准。中国注册临床“悟空 6”里，经治患者的客观缓解率达到 61%。 这套速度背后，有具体的地方产业配套在起作用。 无锡承接省级赋权，实现“就近受理、就近审评、就近核查”，各类办件时效较法定时限平均缩短 30%；同时全域实施研发用物品白名单、进出境特殊物品联合监管，加快研发物料通关；对 I 类创新药临床试验分阶段给予最高 600 万到 3500 万元支持，单个企业年度最高可获 1 亿元资助。 无锡及江苏还形成了覆盖 CXO、风险投资、原料药与制剂生产的全链条生态圈，分子筛选到中试放大可以就近对接。 迪哲医药现代化生产基地外景航拍 更宏观的效率差，业内是有共识的：有跨国药企高管评估，在中国开展药物研发的整体效率大约是美国的 6 倍；启明创投主管合伙人胡旭波则指出，中国新药研发成本较欧美低 50% 至 70% 以上。 放到舒沃替尼身上，就是同一支团队、同一套分子设计，在中国能把临床试验和审评的日历时间压到最短。 别人为什么没做出来，以及别把这件事读过头 同一赛道不是没有对手，而是各有各的卡点。 强生走的是另一条路。埃万妥单抗是抗体，需要静脉注射、需要联合化疗，2024 年 3 月才获 FDA 批准用于一线联合化疗。舒沃替尼是口服小分子单药，给药方式和治疗管理上天然不同。 艾力斯伏美替尼倒在了终点线前。它的全球 III 期 FURVENT 研究中，240mg 组经 BICR 评估的中位无进展生存期是 11.0 个月，对照组化疗是 9.5 个月，HR 0.75、P=0.0654，没有跨过统计学显著性门槛，海外一线注册路径受阻。 鞍石药业的安达艾替尼同属该赛道，2026 年 4 月才获批，比舒沃替尼晚了两年多。 但要小心，别把个案读成“中国创新药全面领先”。 舒沃替尼的本质，是在一个已完成概念验证的成熟靶点上，用分子工程能力做出更优解——先声药业总裁周云曙的评价是，这类项目多属工程化开发，选用的靶点大多是已经成药或完成概念验证的成熟靶点，依靠工程化改造来做，不算源头靶点层面的原始创新。 这条路的另一面是拥挤：中国 Top20 靶点中有 19 个靶点对应的管线数量在全球占比超过 50%。 而价值分配也没那么好看——舒沃替尼 2026 年 7 月把全球权益授予阿斯利康，首付款 6 亿美元、总额最高 15 亿美元，创下国产小分子靶向药首付出海纪录，但业内测算，授权方通常只能拿到首付款和个位数的阶梯分成。 迪哲医药披露的授权首付款相关公告文件 所以回到马克斯那趟飞机。他买到的不只是一盒药，而是一个时间差——中国比美国早了近两年用上这款口服药，2023 年 8 月到 2025 年 7 月，中间隔着的是整条研发与审评链条的效率。 这个时间差能复制到多少个靶点上，取决于中国手里还有多少支像迪哲这样“懂某个靶点”的团队，而不是取决于我们能多快地把热门靶点再做一遍。

Responses were deep and durable, with 65% ongoing at clinical cutoff Results support continued evaluation of the investigational RYBREVANT FASPRO regimen in the ongoing first-line Phase 3 study Data highlight the role of dual-targeting EGFR and MET, key drivers of tumor growth and resistance seen in 80 to 90 percent of HNSCC NEW BRUNSWICK, N.J., Oct. 25, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced new results from Cohort 5 of the Phase 1b/2 OrigAMI-4 study showing deep and durable responses with first-line subcutaneous amivantamab and hyaluronidase-lpuj plus a PD-1 inhibitor and fixed-duration carboplatin chemotherapy in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).1 These findings support the ongoing pivotal Phase 3 OrigAMI-5 study and further expand the clinical development program for subcutaneous amivantamab for patients with head and neck cancer.2 Among patients with HNSCC other than human papillomavirus (HPV)-associated oropharyngeal squamous cell carcinoma (OPSCC), results demonstrated a confirmed overall response rate (ORR) of 77 percent, including 14 percent achieving complete responses.1 Tumor shrinkage was observed in all evaluable patients, and nearly two-thirds of responses remained ongoing at a median follow-up of 10.6 months.1 These findings were presented as a rapid oral presentation at the European Society for Medical Oncology (ESMO) Congress 2026 (Abstract #1539RO). An application for RYBREVANT FASPRO in later-line head and neck cancer is also under Priority Review with the U.S. Food and Drug Administration (FDA). Unmet need remains in first-line head and neck cancer treatment For people with recurrent or metastatic head and neck cancer, the first treatment decision comes at a critical point in an aggressive disease often associated with poor prognosis.3 While some patients benefit from the current standard of care, many experience disease progression while facing symptoms that can profoundly affect daily life, including the ability to eat, swallow and speak.4,5 Nearly 60 percent of patients do not go on to receive subsequent treatment,6 underscoring the need to help more patients achieve meaningful tumor reduction and durable responses from the start. Subcutaneous amivantamab is a bispecific antibody designed to dual-target epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition (MET) while also engaging the immune system.7,8,9 Overexpression of EGFR and MET is seen in 80 to 90 percent of HNSCC tumors and has been implicated in tumor progression and treatment resistance.10 The approach has been well-validated in EGFR-mutated lung cancer where data suggest that targeting both pathways may disrupt disease biology and improve outcomes.11,12 Expert and company perspectives on RYBREVANT FASPRO's role in advancing first-line treatment "The first treatment a patient receives for recurrent or metastatic head and neck cancer can shape everything that follows," said Paul Swiecicki, M.D.,* associate professor of Hematology/Oncology at University of Michigan Rogel Cancer Center. "The responses seen with subcutaneous amivantamab give us reason to think differently about what may be possible from the start of treatment, especially as we see responses across the majority of patients with head and neck cancer, excluding HPV-associated oropharyngeal squamous cell carcinoma, many of which are rapid, deep and persist over time." "We've already seen what subcutaneous amivantamab may offer patients with head and neck cancer after their disease has progressed. Now, we see the potential impact of using this approach earlier in recurrent or metastatic disease," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. "Our experience with RYBREVANT FASPRO in lung cancer has helped establish the potential of dual EGFR/MET targeting, and these results support continued evaluation of this approach in head and neck cancer." RYBREVANT FASPRO demonstrates meaningful anti-tumor activity in first-line disease Cohort 5 of the OrigAMI-4 study evaluated subcutaneous amivantamab in combination with pembrolizumab (PD-1 inhibitor) and up to six cycles of carboplatin in previously untreated patients with recurrent or metastatic HNSCC. Patients received treatment every three weeks following the initial treatment period, with an administration time of five minutes or less. The primary endpoint was ORR, as assessed by investigators using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Response rates were assessed separately in patients with HPV-associated OPSCC (n=7) and patients with all other forms of HNSCC (n=22), given known differences in how these patient populations respond to EGFR-targeted bispecifics.1 Thirty patients received subcutaneous amivantamab in combination with pembrolizumab and carboplatin, and 29 were included in the efficacy analysis. One patient was deemed ineligible. Among the 22 patients with forms of HNSCC other than HPV-associated OPSCC, the confirmed ORR was 77 percent (95 percent confidence interval [CI], 55-92), including complete responses in 14 percent and partial responses in 64 percent. Responses occurred at a median of 9.4 weeks, with 65 percent ongoing at a median follow-up of 10.6 months. Four patients (18 percent) had stable disease and one (5 percent) had progressive disease. Median overall survival was not reached, and 77 percent of patients were alive at one year. The remaining seven patients had HPV-associated OPSCC, with an ORR of 29 percent (95 percent CI, 4-71).1 The safety profile of subcutaneous amivantamab in combination with pembrolizumab and carboplatin was consistent with the individual agents. The most common adverse events were anemia (73 percent), hypoalbuminemia (63 percent), thrombocytopenia (63 percent) and stomatitis (57 percent). Administration-related reactions associated with subcutaneous amivantamab occurred in 13 percent of patients, with no Grade 3 or higher events reported.1 The Cohort 5 findings build on earlier first-line results from the OrigAMI-4 program, including Cohort 2 data evaluating subcutaneous amivantamab in combination with pembrolizumab recently published in Clinical Cancer Research.13 About the OrigAMI-4 study OrigAMI-4 (NCT06385080) is an open-label Phase 1b/2 study evaluating RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) in recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). The study includes six cohorts exploring RYBREVANT FASPRO across different treatment settings and regimens.14 Cohort 5 of the OrigAMI-4 study evaluated RYBREVANT FASPRO, administered every three weeks, in combination with pembrolizumab and carboplatin in patients with recurrent or metastatic head and neck squamous cell carcinoma receiving first-line treatment whose tumors tested positive for programmed death-ligand 1 (PD-L1), with a combined positive score (CPS) of 1 or greater. The primary endpoint was ORR, as assessed by investigators using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).† 14 About head and neck squamous cell carcinoma Head and neck squamous cell carcinoma (HNSCC) is the most common form of head and neck cancer, a group of cancers that arise in the mouth, throat, voice box, sinuses, nasal cavity and salivary glands.15 It represents approximately 4.5 percent of all cancers worldwide and is the seventh most common cancer globally.15 Major risk factors include tobacco and alcohol use, as well as infection with high-risk human papillomavirus (HPV).15 Approximately 80 percent of recurrent or metastatic HNSCC are not driven by HPV, and are typically associated with poorer prognosis and reduced response to treatment.15,16 Despite advances in surgery, radiation, chemotherapy, and immunotherapy, many patients ultimately progress to advanced, recurrent or metastatic disease.17,18 About RYBREVANT FASPRO and RYBREVANT® RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) received U.S. FDA approval in December 2025 and is approved in multiple markets worldwide for the treatment of adults with EGFR-mutated non-small cell lung cancer (NSCLC), including those with exon 19 deletions, exon 21 L858R substitution mutations, and exon 20 insertion mutations. It is the only subcutaneous therapy approved for these EGFR-mutated NSCLC populations and may be used as monotherapy or in combination with LAZCLUZE® (lazertinib) or chemotherapy, depending on the specific mutation and treatment setting. For eligible patients, RYBREVANT FASPRO offers a once-monthly dosing option following initial weekly dosing. RYBREVANT FASPRO is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology. RYBREVANT FASPRO is approved in the U.S. for the same indications as intravenous RYBREVANT (amivantamab-vmjw) across multiple markets. RYBREVANT is a first-in-class, fully human bispecific antibody targeting EGFR and MET, designed to inhibit tumor growth while engaging the immune system. The National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®)‡ 19 include amivantamab-vmjw (RYBREVANT) across its FDA-approved treatment settings, including as a Category 1 preferred option in combination with lazertinib (LAZCLUZE) for first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations. Subcutaneous amivantamab and hyaluronidase-lpuj (RYBREVANT FASPRO) may be substituted for IV amivantamab-vmjw (RYBREVANT®) where appropriate. See the latest NCCN Guidelines® for NSCLC for complete information.§ || The NCCN Guidelines for Central Nervous System Cancers also include amivantamab (RYBREVANT)-based regimens, including in combination with lazertinib (LAZCLUZE), as the only NCCN-preferred combination options for patients with EGFR-mutated NSCLC and brain metastases.§ || Beyond NSCLC, RYBREVANT-based therapies are being investigated across other solid tumors, including head and neck and colorectal cancers. The legal manufacturer for RYBREVANT FASPRO and RYBREVANT is Janssen Biotech, Inc. For more information, visit . RYBREVANT FASPRO and RYBREVANT® IMPORTANT SAFETY INFORMATION20, 21 INDICATIONS RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) and RYBREVANT (amivantamab-vmjw) are indicated: in combination with LAZCLUZE (lazertinib) for the first-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 first-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 FOR RYBREVANT FASPRO AND RYBREVANT CONTRAINDICATIONS RYBREVANT FASPRO is contraindicated in patients with known hypersensitivity to hyaluronidase or to any of its excipients. WARNINGS AND PRECAUTIONS Hypersensitivity and Administration-Related Reactions with RYBREVANT FASPRO RYBREVANT FASPRO can cause hypersensitivity and administration-related reactions (ARR); signs and symptoms of ARR include dyspnea, flushing, 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 ARR occurred in 13% of patients, including 0.5% Grade 3. Of the patients who experienced ARR, 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, flushing, 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 modifications 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 modifications occurred in 46%, and permanent discontinuation of RYBREVANT in 2.8% of patients. 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 modifications 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 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 confirmed. 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 first 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 (n=421), 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 first 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 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 modification. 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 and LAZCLUZE, prophylactic and concomitant medications are recommended to reduce the risk and severity of dermatologic adverse reactions. Instruct patients to limit sun 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. Hepatotoxicity LAZCLUZE in combination with amivantamab can cause severe hepatotoxicity (including increased ALT and AST). RYBREVANT with LAZCLUZE In MARIPOSA, based on adverse reaction data, hepatotoxicity occurred in 49% of patients treated with LAZCLUZE, including Grade 3 in 9.3% of patients and Grade 4 in 0.5%. LAZCLUZE was interrupted for an adverse reaction of hepatotoxicity in 8% of patients, the dose was reduced in 1.4% and permanently discontinued in 0.2%. Perform liver function tests (including ALT, AST, and total bilirubin) before initiation of LAZCLUZE and during treatment, as clinically indicated. Withhold, reduce the dose, or permanently discontinue LAZCLUZE and amivantamab 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. 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 and continue LAZCLUZE based on severity. Embryo-Fetal Toxicity 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 effective 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 effusion and IRRs (RYBREVANT) (2.1% each). Fatal ARs occurred in 7% of patients due to death not otherwise specified (1.2%); sepsis and respiratory 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 fibrillation (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 specified. 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%). 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-491009v2 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 or at . Follow us at @JNJInnovMed. 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 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; 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 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 filings with the Securities and Exchange Commission. Copies of these filings are available online at , , 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. *Paul Swiecicki, M.D., has served as a consultant to Johnson & Johnson; he has not been paid for any media work. † RECIST (version 1.1) refers to Response Evaluation Criteria in Solid Tumors, which is a standard way to measure how well solid tumors respond to treatment and is based on whether tumors shrink, stay the same or get bigger. ‡ 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. 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