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Johnson & Johnson Highlights Ambition to Transform the Treatment of Prostate Cancer and Bladder Cancer through Data Presentations at ASCO GU
Clinical and real-world evidence data support treatment with ERLEADA® (apalutamide) and niraparib plus abiraterone acetate given with prednisone in patients with prostate cancer Additional updates will be presented on innovative targeted releasing systems TAR-200 and TAR-210 in bladder cancer
U.S. Food and Drug Administration Grants Full Approval for BALVERSA® to Treat Locally Advanced or Metastatic Bladder Cancer with Select Genetic Alterations
BALVERSA® is the First and Only Targeted Therapy for Patients with Locally Advanced or Metastatic Urothelial Carcinoma and Susceptible Fibroblast Growth Factor Receptor Alterations Phase 3 THOR Study Showed a 36 Percent Reduction in the Risk of Death with BALVERSA® Versus Chemotherapy in Patients Data were featured at the European Society for Medical Oncology (ESMO) 2023 Congress and in The New England Journal of Medicine
Johnson & Johnson to Acquire Ambrx, Advancing Next Generation Antibody Drug Conjugates to Transform the Treatment of Cancer
Portfolio of Clinical and Preclinical Programs, Including Lead Product Candidate ARX517, a Prostate-Specific Membrane Antigen (PSMA)-Targeting Antibody Drug Conjugate (ADC), Strengthens Johnson & Johnson’s Commitment to Oncology Innovation Novel Technology Platform Sets Stage for the Development of Next Generation ADCs and Targeted Oncologic Therapeutics
Janssen Submits Marketing Authorisation Application to the European Medicines Agency Seeking Approval of Lazertinib, in combination with RYBREVANT®▼ (amivantamab), for the First-Line Treatment of Patients with EGFR-Mutated Non-Small Cell Lung Cancer
The submission is supported by data from the Phase 3 MARIPOSA study, which featured in a Late-Breaking Presidential Symposium session at the 2023 ESMO Congress1 Lazertinib is a highly selective, central nervous system-penetrant, third-generation EGFR tyrosine kinase inhibitor2,3
Johnson & Johnson Submits Supplemental Biologics License Application and New Drug Application to U.S. FDA Seeking Approval of RYBREVANT® (amivantamab-vmjw) Plus Lazertinib for the Treatment of Patients with EGFR-Mutated Non-Small Cell Lung Cancer (NSCLC)
Submissions supported by data from landmark Phase 3 MARIPOSA study, which showed statistically significant and clinically meaningful improvement in progression-free survival in patients with EGFR-mutated advanced NSCLC treated with RYBREVANT® plus lazertinib versus osimertinib
DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based quadruplet therapy regimen shows significant improvement in outcomes for patients with transplant-eligible newly diagnosed multiple myeloma
DARZALEX FASPRO®-based induction, consolidation and maintenance regimen reduced risk of progression or death by 58 percent compared to standard of care regimen First presentation of data from Phase 3 PERSEUS study highlighted in late-breaking abstract session at ASH 2023 and simultaneously published in The New England Journal of Medicine
New Analyses Demonstrate Versatility and Continued Efficacy of TALVEY™ in the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
Analysis from MonumenTAL-1 study showed patients with relapsed or refractory multiple myeloma treated with TALVEY™ were subsequently treated effectively with several classes of therapy, including CAR-T Additional presentations at the 2023 ASH Annual Meeting showed potential improvement in adverse events among patients who received reduced intensity dosing and first-ever results from TALVEY™ combination study
Treatment with CARVYKTI® (ciltacabtagene autoleucel) Resulted in Clinically Meaningful Improvements in Health-Related Quality of Life and Reductions in Disease-Specific Symptoms in Patients with Earlier-Line Multiple Myeloma
Oral presentations at the 2023 ASH Annual Meeting include patient-reported outcomes from the CARTITUDE-4 study and longer-term efficacy and safety data from CARTITUDE-2 study cohorts A and B, show the promise of CARVYKTI® in earlier lines of treatment
Johnson & Johnson highlights its preeminent leadership in hematology through differentiated blood cancer portfolio and pipeline with new clinical and real-world data at ASH
Data highlights strength of multi-target, multi-platform multiple myeloma portfolio and continued innovation in B-cell malignancies to transform patient outcomes
Phase 3 MARIPOSA-2 Study Shows RYBREVANT® (amivantamab-vmjw) Plus Chemotherapy Given with or without Lazertinib Reduced Risk of Disease Progression or Death by 56 and 52 Percent Respectively in Patients with EGFR-Mutated Non-Small Cell Lung Cancer who Progressed on or after Osimertinib
These RYBREVANT® regimens are the first to show improvement in progression-free survival compared to chemotherapy in patients with EGFR-mutated advanced non-small cell lung cancer (NSCLC) following prior osimertinib treatment Late-breaking results from MARIPOSA-2 study presented in a Presidential Symposium at 2023 ESMO Congress and simultaneously published in Annals of Oncology
Landmark Phase 3 MARIPOSA Study Shows RYBREVANT® (amivantamab-vmjw) Plus Lazertinib Resulted in 30 Percent Reduction in Risk of Disease Progression or Death Compared to Osimertinib in Patients with EGFR-Mutated Non-Small Cell Lung Cancer
Early data show an overall survival trend favoring the combination of RYBREVANT® and lazertinib compared to osimertinib; consistent results seen in patients with and without brain metastases Late-breaking results from the MARIPOSA study featured in a Presidential Symposium at 2023 ESMO Congress
TAR-200 Intravesical Delivery System Results Show 77 Percent Complete Response Rate in Patients with Bacillus-Calmette-Guérin Unresponsive, High-Risk Non-Muscle-Invasive Bladder Cancer
Phase 2b SunRISe-1 study results showed sustained, durable complete responses beyond one year with intravesical gemcitabine delivery system
First Results with Erdafitinib-Releasing Intravesical Delivery System (TAR-210) Show Early Evidence of Positive Clinical Activity in Patients with Non-Muscle-Invasive Bladder Cancer with Select Fibroblast Growth Factor Receptor Alterations
Investigational TAR-210 first-in-human results highlight the potential for local sustained release of erdafitinib with a novel intravesical delivery system Phase 1 results show a manageable safety profile with limited systemic toxicity, and early complete responses in patients with high-risk and intermediate-risk NMIBC
Final Multivariate Analysis from the Phase 3 MAGNITUDE Study Shows Trend Toward Improvement in Overall Survival in Patients with Metastatic Castration-Resistant Prostate Cancer with BRCA Alterations Treated with Niraparib and Abiraterone Acetate Plus Prednisone
Niraparib and abiraterone acetate plus prednisone combination therapy also showed clinically relevant improvement versus standard of care in time to symptomatic progression and time to cytotoxic chemotherapy
New Data from Phase 3 PAPILLON Study Show RYBREVANT® (amivantamab-vmjw) Plus Chemotherapy Resulted in 60 Percent Reduction in Risk of Disease Progression or Death in Patients with Previously Untreated EGFR Exon 20 Insertion Mutation-Positive Non-Small Cell Lung Cancer
Data show the potential impact of RYBREVANT® and chemotherapy combination as first-line treatment for patients with advanced non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations Late-breaking data presented in a Presidential Symposium at 2023 ESMO Congress and simultaneously published in The New England Journal of Medicine
Results from Phase 2 THOR-2 Study Show Improved Rates of Recurrence-Free Survival in Patients with High-Risk Non-Muscle-Invasive Bladder Cancer with Select Fibroblast Growth Factor Receptor Alterations Treated with BALVERSA® (erdafitinib) Versus Chemotherapy
Data from Cohort 1 of the Phase 2 THOR-2 study showed oral erdafitinib reduced the risk of disease recurrence or death compared with intravesical standard-of-care chemotherapy
Janssen Aims to Define New Standards of Care in the Treatment of Solid Tumor Cancers with Transformative Data Planned for Presentation at ESMO
Three Phase 3 RYBREVANT® (amivantamab-vmjw) studies (MARIPOSA, MARIPOSA-2 and PAPILLON) in EGFR-mutated lung cancer achieved statistically significant and clinically meaningful progression-free survival endpoints and will be presented in Presidential Symposium sessions New results for investigational TAR-200 and TAR-210 novel intravesical delivery system highlight potential for transformational outcomes in the treatment of bladder cancer
Landmark Phase 3 MARIPOSA Study Meets Primary Endpoint Resulting in Statistically Significant and Clinically Meaningful Improvement in Progression-Free Survival for RYBREVANT® (amivantamab-vmjw) plus Lazertinib Versus Osimertinib in Patients with EGFR-Mutated Non-Small Cell Lung Cancer
Planned interim overall survival analysis showed a trend favoring the combination of RYBREVANT® and lazertinib compared to osimertinib* First pivotal study to show a clinically meaningful benefit in a chemotherapy-free regimen versus osimertinib
