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RYBREVANT® Combination Extends Survival and Significantly Reduces Common EGFR and MET Resistance Mutations Seen with Osimertinib-Based Treatment
BARCELONA, Spain, Sept. 6, 2025 — Johnson & Johnson (JNJ) has announced new analyses from the Phase 3 MARIPOSA study, showcasing a significant advancement in the treatment of EGFR-mutated non-small cell lung cancer (NSCLC). The data reveal that first-line treatment with RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE® (lazertinib) substantially reduces the development of epidermal growth factor receptor (EGFR)- and MET-driven resistance compared with osimertinib in patients with EGFR-mutated NSCLC with exon 19 deletion (ex19del) or L858R mutations. These findings, presented at the International Association for the Study of Lung Cancer (IASLC) 2025 World Congress on Lung Cancer (WCLC), build upon the combination’s previously reported overall survival benefit in a chemotherapy-free regimen, projected to exceed four years – a year beyond the median observed with osimertinib. The results suggest a potentially transformative impact on the disease biology by preventing acquired resistance.
Resistance to third-generation EGFR tyrosine kinase inhibitors (TKIs), such as osimertinib, remains a significant obstacle to long-term disease control. This underscores the demand for next-generation strategies that can more effectively prevent the development of resistance to EGFR and MET, thereby extending survival for patients with EGFR-mutated lung cancer.
Professor Sanjay Popat, medical oncologist at the Royal Marsden Hospital and the Institute of Cancer Research in the United Kingdom, noted that TKI monotherapy may no longer be sufficient in the first-line treatment of EGFR-mutated lung cancer. He further stated that the MARIPOSA results demonstrate that combining RYBREVANT with LAZCLUZE represents a significant step forward, mitigating EGFR- and MET-driven resistance associated with TKI-based therapy and providing patients with a more durable initial response.
The updated MARIPOSA study analyses align with prior data presented at the European Society for Medical Oncology (ESMO) 2024 Congress, and confirm that patients treated with RYBREVANT® plus LAZCLUZE® experienced a lower incidence of the two primary resistance mechanisms (MET amplification and EGFR mutations) compared to those treated with osimertinib alone. Specifically, MET amplifications were observed in just three percent of patients on the combination therapy versus 13 percent on osimertinib (P=0.002), while secondary EGFR mutations (such as C797S) were significantly less prevalent in the RYBREVANT® plus LAZCLUZE® arm (1 percent vs 8 percent; P=0.01). Acquired MET amplification led to early discontinuation in 23 percent of patients on osimertinib within six months, compared with only four percent on RYBREVANT® plus LAZCLUZE®. Moreover, acquired resistance was rare among patients who remained on the combination therapy for at least six months, with MET amplification observed in only two percent of patients and no EGFR C797S mutations detected. The analysis also revealed greater overall genetic diversity of resistance in patients treated with osimertinib, particularly those with EGFR- and MET-based alterations.
Joshua Bauml, M.D., Vice President, Lung Cancer Disease Area Leader, Johnson & Johnson Innovative Medicine, emphasized the pivotal nature of first-line treatment decisions for EGFR-mutated NSCLC, noting their influence on disease progression. He stated that the data demonstrate RYBREVANT plus LAZCLUZE alters the biology of disease by blocking resistance pathways commonly exploited by cancers to circumvent treatment. By proactively preventing resistance in the frontline setting, this combination has the potential to extend survival and preserve future treatment options for patients. These advantages are not observed with prior therapies or presently emerging combinations.
The safety profile of RYBREVANT® plus LAZCLUZE® remained consistent with previous analyses, with no new safety signals emerging during extended follow-up. Notably, most adverse events (grade 3 or higher) occurred early in the treatment course. RYBREVANT® studies suggest that implementing preemptive or prophylactic measures can mitigate the incidence and severity of skin reactions, infusion-related reactions, and venous thromboembolic events.
RYBREVANT® plus LAZCLUZE® has been approved in the United States, Europe, and other global markets as a first-line treatment for EGFR-mutated NSCLC based on the findings of the Phase 3 MARIPOSA study.
About the MARIPOSA Study
The MARIPOSA study (NCT04487080) is a randomized, Phase 3 trial involving 1,074 patients. It evaluates the efficacy of RYBREVANT® in combination with LAZCLUZE® compared to osimertinib and LAZCLUZE® alone in the first-line treatment of patients with locally advanced or metastatic NSCLC harboring EGFR exon 19 deletion (ex19del) or substitution mutations. The primary endpoint is progression-free survival (PFS), assessed by Blinded Independent Central Review (BICR) using RECIST v1.1 guidelines. Secondary endpoints include overall survival (OS), objective response rate (ORR), duration of response (DoR), progression-free survival after first subsequent therapy (PFS2), and intracranial PFS.
About RYBREVANT®
RYBREVANT® (amivantamab-vmjw) is a fully human bispecific antibody targeting EGFR and MET with immune cell-directing activity. It is approved in the U.S., Europe, and other markets as monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
RYBREVANT® is also approved in the U.S., Europe, and other markets in combination with chemotherapy (carboplatin and pemetrexed) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, detected by an FDA-approved test.
Furthermore, RYBREVANT® is approved in the U.S., Europe, and other markets 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, detected by an FDA-approved test.
RYBREVANT® is approved in the U.S., Europe, and other markets in combination with chemotherapy (carboplatin-pemetrexed) for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR TKI.
Subcutaneous amivantamab is approved in Europe in combination with LAZCLUZE® for the first-line treatment of adult patients with advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, and as a monotherapy for the treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy. A Biologics License Application (BLA) was submitted to the U.S. FDA for this indication.
The National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for NSCLC prefer next-generation sequencing–based strategies over polymerase chain reaction–based approaches for the detection of EGFR exon 20 insertion variants. The NCCN Guidelines include:
- Amivantamab-vmjw (RYBREVANT®) plus lazertinib (LAZCLUZE®) as a Category 1 recommendation for first-line therapy in patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations.
- Amivantamab-vmjw (RYBREVANT®) plus chemotherapy as a Category 1 recommendation for patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations who experienced disease progression after treatment with osimertinib.
- Amivantamab-vmjw (RYBREVANT®) plus chemotherapy as a Category 1 recommendation for first-line therapy in treatment-naive patients with newly diagnosed advanced or metastatic EGFR exon 20 insertion mutation-positive advanced NSCLC.
- Amivantamab-vmjw (RYBREVANT®) as a Category 2A recommendation for patients that have progressed on or after platinum-based chemotherapy with or without an immunotherapy and have EGFR exon 20 insertion mutation-positive NSCLC.
RYBREVANT® is currently being investigated in several clinical trials in NSCLC, evaluating its potential in various settings and combinations.
The legal manufacturer for RYBREVANT® is Janssen Biotech, Inc.
For more information, visit: https://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 efficacy and safety of LAZCLUZE® from the Phase 3 LASER301 study was published in The Journal of Clinical Oncology in 2023.
The legal manufacturer for LAZCLUZE® is Janssen Biotech, Inc. and Yuhan Corporation.
About Non-Small Cell Lung Cancer
Lung cancer is one of the most prevalent cancers worldwide, with NSCLC accounting for 80-85% of all lung cancer cases. Adenocarcinoma, squamous cell carcinoma, and large cell carcinoma are the primary NSCLC subtypes. EGFR alterations are among the most common driver mutations, impacting the receptor tyrosine kinase responsible for cell growth and division. EGFR mutations are observed in 10-15% of Western NSCLC patients with adenocarcinoma and in 40-50% of Asian patients. The EGFR ex19del and EGFR L858R mutations are the most common EGFR mutations. The five-year survival rate for patients with advanced NSCLC and EGFR mutations treated with EGFR tyrosine kinase inhibitors (TKIs) remains below 20%. EGFR exon 20 insertion mutations represent the third most common activating EGFR mutation. Patients with EGFR exon 20 insertion mutations face a poorer real-world five-year overall survival (OS) of 8% in the frontline setting, compared to 19% for patients with EGFR ex19del or L858R mutations.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Infusion-Related Reactions
RYBREVANT® can induce infusion-related reactions (IRR), including anaphylaxis. Signs and symptoms include dyspnea, flushing, fever, chills, nausea, chest discomfort, hypotension, and vomiting. The median time to IRR onset is approximately 1 hour.
RYBREVANT® with LAZCLUZE®
RYBREVANT® in combination with LAZCLUZE® can cause infusion-related reactions. In MARIPOSA, IRRs occurred in 63% of patients treated with RYBREVANT® in combination with LAZCLUZE®, including Grade 3 in 5% and Grade 4 in 1% of patients. The incidence of infusion modifications due to IRR was 54% of patients, and IRRs leading to dose reduction of RYBREVANT® occurred in 0.7% of patients. Infusion-related reactions leading to permanent discontinuation of RYBREVANT® occurred in 4.5% of patients receiving RYBREVANT® in combination with LAZCLUZE®.
RYBREVANT® with Carboplatin and Pemetrexed
Based on the pooled safety population, IRR occurred in 50% of patients treated with RYBREVANT® in combination with carboplatin and pemetrexed, including Grade 3 (3.2%) adverse reactions. The incidence of infusion modifications due to IRR was 46%, and 2.8% of patients permanently discontinued RYBREVANT® due to IRR.
RYBREVANT® as a Single Agent
In CHRYSALIS, IRR occurred in 66% of patients treated with RYBREVANT®. Among patients receiving treatment on Week 1 Day 1, 65% experienced an IRR, while the incidence of IRR was 3.4% with the Day 2 infusion, 0.4% with the Week 2 infusion, and cumulatively 1.1% with subsequent infusions. Of the reported IRRs, 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. The incidence of infusion modifications due to IRR was 62%, and 1.3% of patients permanently discontinued RYBREVANT® due to IRR.
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 infusion-related reactions. Monitor patients for signs and symptoms of infusion reactions during RYBREVANT® infusion 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® can cause severe and fatal interstitial lung disease (ILD)/pneumonitis.
RYBREVANT® with LAZCLUZE®
In MARIPOSA, ILD/pneumonitis occurred in 3.1% of patients treated with RYBREVANT® in combination with LAZCLUZE®, including Grade 3 in 1.0% and Grade 4 in 0.2% of patients. There was one fatal case (0.2%) 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% treated with RYBREVANT® in combination with carboplatin and pemetrexed 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 treated with RYBREVANT®, 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). For patients receiving RYBREVANT® in combination with LAZCLUZE®, immediately withhold both drugs in patients with suspected ILD/pneumonitis and permanently discontinue if ILD/pneumonitis is confirmed. For patients receiving RYBREVANT® as a single agent or in combination with carboplatin and pemetrexed, immediately withhold RYBREVANT® in patients with suspected ILD/pneumonitis and permanently discontinue if ILD/pneumonitis is confirmed.
Venous Thromboembolic (VTE) Events with Concomitant Use of RYBREVANT® and LAZCLUZE®
RYBREVANT® in combination with LAZCLUZE® can cause serious and fatal venous thromboembolic (VTE) events, including deep vein thrombosis and pulmonary embolism. The majority of these events occurred during the first four months of therapy.
In MARIPOSA, VTEs occurred in 36% of patients receiving RYBREVANT® in combination with LAZCLUZE®, 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® and LAZCLUZE® based on severity. Once anticoagulant treatment has been initiated, resume 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® and continue treatment with LAZCLUZE® at the same dose level at the discretion of the healthcare provider.
Dermatologic Adverse Reactions
RYBREVANT® can cause severe rash including toxic epidermal necrolysis (TEN), dermatitis acneiform, pruritus, and dry skin.
RYBREVANT® with LAZCLUZE®
In MARIPOSA, rash occurred in 86% of patients treated with RYBREVANT® in combination with LAZCLUZE®, 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 treated with RYBREVANT® in combination with carboplatin and pemetrexed, 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 treated with RYBREVANT® as a single agent, including Grade 3 rash 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% of patients, and RYBREVANT® was permanently discontinued due to rash in 0.7% of patients.
Toxic epidermal necrolysis occurred in one patient (0.3%) treated with RYBREVANT® as a single agent.
Instruct patients to limit sun exposure during and for 2 months after treatment with RYBREVANT® or LAZCLUZE® in combination with RYBREVANT®. Advise patients to wear protective clothing and use broad-spectrum UVA/UVB sunscreen. Alcohol-free (e.g., isopropanol-free, ethanol-free) emollient cream is recommended for dry skin.
When initiating RYBREVANT® treatment with or without LAZCLUZE®, administer alcohol-free emollient cream to reduce the risk of dermatologic adverse reactions. Consider prophylactic measures (e.g. use of oral antibiotics) to reduce the risk of dermatologic reactions. If skin reactions develop, start 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® in combination with LAZCLUZE®, withhold, reduce the dose, or permanently discontinue both drugs based on severity. For patients receiving RYBREVANT® as a single agent or in combination with carboplatin and pemetrexed, withhold, dose reduce or permanently discontinue RYBREVANT® based on severity.
Ocular Toxicity
RYBREVANT® can cause ocular toxicity including keratitis, blepharitis, dry eye symptoms, conjunctival redness, blurred vision, visual impairment, ocular itching, eye pruritus, and uveitis.
RYBREVANT® with LAZCLUZE®
In MARIPOSA, ocular toxicity occurred in 16% of patients treated with RYBREVANT® in combination with LAZCLUZE®, 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 treated with RYBREVANT® in combination with carboplatin and pemetrexed. 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 treated with RYBREVANT®. All events were Grade 1-2.
Promptly refer patients with new or worsening eye symptoms to an ophthalmologist. Withhold, reduce the dose, or permanently discontinue RYBREVANT® based on severity.
Embryo-Fetal Toxicity
Based on its mechanism of action and findings from animal models, RYBREVANT® and LAZCLUZE® can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential of the potential risk to the fetus.
Advise female patients of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of RYBREVANT®.
Advise females of reproductive potential to use effective contraception during treatment with LAZCLUZE® and for 3 weeks after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with LAZCLUZE® and for 3 weeks after the last dose.
Adverse Reactions
RYBREVANT® with LAZCLUZE®
For the 421 patients in the MARIPOSA clinical trial who received RYBREVANT® in combination with LAZCLUZE®, the most common adverse reactions (≥20%) were rash (86%), nail toxicity (71%), infusion-related reactions (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%), nausea (21%), and ocular toxicity (16%). 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 adverse reactions occurred in 49% of patients who received RYBREVANT® in combination with LAZCLUZE®. Serious adverse reactions occurring in ≥2% of patients included VTE (11%), pneumonia (4%), ILD/pneumonitis and rash (2.9% each), COVID-19 (2.4%), and pleural effusion and infusion-related reaction (RYBREVANT®) (2.1% each). Fatal adverse reactions occurred in 7% of patients who received RYBREVANT® in combination with LAZCLUZE® 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
For the 130 patients in the MARIPOSA-2 clinical trial who received RYBREVANT® in combination with carboplatin and pemetrexed, the most common adverse reactions (≥20%) were rash (72%), infusion-related reactions (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 adverse reactions occurred in 32% of patients who received RYBREVANT® in combination with carboplatin and pemetrexed. Serious adverse reactions in >2% of patients included dyspnea (3.1%), thrombocytopenia (3.1%), sepsis (2.3%), and pulmonary embolism (2.3%). Fatal adverse reactions occurred in 2.3% of patients who received RYBREVANT® in combination with carboplatin and pemetrexed; these included respiratory failure, sepsis, and ventricular fibrillation (0.8% each).
For the 151 patients in the PAPILLON clinical trial who received RYBREVANT® in combination with carboplatin and pemetrexed, the most common adverse reactions (≥20%) were rash (90%), nail toxicity (62%), stomatitis (43%), infusion-related reaction (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 adverse reactions occurred in 37% of patients who received RYBREVANT® in combination with carboplatin and pemetrexed. Serious adverse reactions in ≥2% of patients included rash, pneumonia, ILD, pulmonary embolism, 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
For the 129 patients in the CHRYSALIS clinical trial who received RYBREVANT® as a single agent, the most common adverse reactions (≥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 adverse reactions occurred in 30% of patients who received RYBREVANT®. Serious adverse reactions in ≥2% of patients included pulmonary embolism, 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 read full Prescribing Information for RYBREVANT®.
Please read full Prescribing Information for LAZCLUZE®.
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 http://www.innovativemedicine.jnj.com/. 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® or LAZCLUZE®. 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 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.
*Professor Sanjay Popat 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. 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
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