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RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) significantly outperforms standard of care in first-line EGFR-mutated lung cancer with compelling new data at ELCC 2025
Median overall survival improvement projected to exceed one year with much-anticipated overall survival analysis showing statistically superior result versus osimertinib Preventative dermatologic regimen meets primary endpoint and enhances patient experience
Johnson & Johnson’s DARZALEX® (daratumumab) subcutaneous-based regimen receives positive CHMP opinion for patients with newly diagnosed multiple myeloma, regardless of transplant eligibility
If approved, daratumumab will be the only anti-CD38 available for all patient types across newly diagnosed multiple myeloma, cementing daratumumab as a foundational therapy in the frontline setting. Recommendation supported by results from CEPHEUS, the fifth Phase 3 study of daratumumab to demonstrate improved progression free survival in the frontline setting.1,2,3,4
CHMP recommends subcutaneous RYBREVANT®▼ (amivantamab) for the treatment of patients with advanced EGFR-mutated non-small cell lung cancer
Data from the Phase 3 PALOMA-3 study showed non-inferiority to intravenous administration meeting both co-primary pharmacokinetic (PK) endpoints, as well as a five-fold reduction in infusion-related reactions and fewer venous thromboembolic events1 CHMP has issued a positive opinion for an extension of marketing authorisation for subcutaneous amivantamab dosed every two weeks
European Commission approves LAZCLUZE®▼ (lazertinib) in combination with RYBREVANT®▼ (amivantamab) for the first-line treatment of patients with EGFR-mutated advanced non-small cell lung cancer
Latest topline data from the Phase 3 MARIPOSA study shows amivantamab plus lazertinib is the first regimen to demonstrate superior overall survival benefit compared to the current standard of care osimertinib1 Median overall survival improvement is expected to exceed one year1
New Drug Application initiated with U.S. FDA for TAR-200, the first and only intravesical drug releasing system for patients with BCG-unresponsive high-risk non-muscle-invasive bladder cancer
Application accepted for U.S. FDA Real-Time Oncology Review (RTOR) based on Phase 2b SunRISe-1 study showing highest single-agent complete response rate of 83.5 percent1
Warm autoimmune hemolytic anemia (wAIHA) research presented by Johnson & Johnson highlights profound disease burden and unmet need for targeted treatment options
Abstracts presented at ASH 2024 provide insight into the patient experience given the unpredictable nature of wAIHA, a rare autoantibody disease, and the uncertainty of current treatment approaches used to manage the condition There are no FDA-approved therapies indicated for wAIHA, and patients living with this condition need targeted treatment options with a proven safety and efficacy profile Johnson & Johnson is evaluating nipocalimab for the potential treatment of wAIHA in the Phase 2/3 ENERGY study, which is expected to read out in 2025
DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based regimens demonstrate improved rates of minimal residual disease (MRD) negativity and progression-free survival in patients with newly diagnosed multiple myeloma
New analysis from Phase 3 CEPHEUS study demonstrates 85 percent of patients who achieved MRD negativity (10-6) with DARZALEX FASPRO® were progression free at 4.5 years Subgroup analysis from Phase 3 AURIGA study show higher rates of MRD-negative conversion in patient populations disproportionately impacted by multiple myeloma
TECVAYLI® (teclistamab-cqyv) demonstrates potential as frontline combination therapy for patients with newly diagnosed multiple myeloma
100 percent of evaluable patients for minimal residual disease (MRD) testing achieved MRD negativity in MajesTEC-5 as induction therapy and MajesTEC-4 as maintenance therapy
DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) shows 51 percent reduction in risk of progression to active multiple myeloma for patients with high-risk smoldering multiple myeloma
First and only subcutaneous anti-CD38 therapy demonstrating potential to prevent end-organ damage, and extend progression-free survival and overall survival based on findings from Phase 3 AQUILA study
Johnson & Johnson to showcase strength of its broad hematology portfolio and pipeline at the 2024 American Society of Hematology Annual Meeting
More than 90 presentations of clinical trial and real-world data highlight potentially practice-changing evidence and commitment to pioneer the next wave of therapies for patients with hematologic malignancies
CHMP recommends RYBREVANT®▼ (amivantamab) in combination with LAZCLUZE®▼ (lazertinib) for the first-line treatment of patients with EGFR-mutated advanced non-small cell lung cancer
The amivantamab plus lazertinib combination regimen offers potential to provide new standard of care as first-line option for adult patients with advanced NSCLC with EGFR ex19del or L858R substitution mutations1 In the Phase 3 MARIPOSA study, amivantamab plus lazertinib significantly reduced risk of disease progression or death by 30 percent versus osimertinib monotherapy1
Johnson & Johnson submits applications in the U.S. and EU seeking approval of DARZALEX FASPRO® / DARZALEX® as subcutaneous monotherapy for high-risk smoldering multiple myeloma
If approved, DARZALEX FASPRO® will become the first treatment option for patients with smoldering multiple myeloma at high-risk of developing multiple myeloma, offering a novel approach to treat before the onset of active disease and the occurrence of end organ damage
DARZALEX® (daratumumab)-SC based quadruplet regimen approved by the European Commission for patients with newly diagnosed multiple myeloma who are transplant-eligible
Phase 3 PERSEUS study of daratumumab subcutaneous (SC) formulation in combination with bortezomib, lenalidomide and dexamethasone induction and consolidation, followed by daratumumab SC and lenalidomide maintenance showed a 58 percent reduction in risk of disease progression or death1 New regimen reinforces daratumumab SC as a foundational element for optimising frontline treatment of patients with newly diagnosed multiple myeloma, and significantly delaying disease progression2
Johnson & Johnson submits application to the European Medicines Agency for DARZALEX® (daratumumab) SC-based quadruplet regimen for newly diagnosed multiple myeloma patients
Submission supported by data from the Phase 3 CEPHEUS study for the treatment of patients with newly diagnosed multiple myeloma for whom transplant is not planned as initial therapy.1 Data showed that the daratumumab subcutaneous formulation-based quadruplet regimen significantly improved minimal residual disease (MRD)-negativity and reduced the risk of progression or death compared to standard of care regimen.1
ERLEADA® (apalutamide) demonstrates statistically significant and clinically meaningful improvement in overall survival compared to enzalutamide in patients with metastatic castration-sensitive prostate cancer
Largest head-to-head real-world study in mCSPC demonstrated that ERLEADA® reduced risk of death by 23 percent at 24 months compared to enzalutamide
Johnson & Johnson files for U.S. FDA approval of DARZALEX FASPRO®-based quadruplet regimen for newly diagnosed multiple myeloma patients for whom transplant is not planned
Results from CEPHEUS study highlight DARZALEX FASPRO® quadruplet regimen as a potential standard of care in newly diagnosed patients regardless of transplant eligibility New indication would be the first FDA-approved treatment regimen for newly diagnosed multiple myeloma based on a study with MRD-negativity as the primary endpoint
Johnson & Johnson to invest more than $2 billion in new, advanced technology manufacturing facility in North Carolina to support robust portfolio growth
Johnson & Johnson (NYSE: JNJ) today announced an investment of more than $2 billion to build a state-of-the-art biologics manufacturing facility in Wilson, North Carolina. The new facility will expand production of the Company’s portfolio and pipeline of innovative biologics in support of Johnson & Johnson’s broader plan to advance more than 70 novel therapy and product expansion filings and launches by the end of the decade.
