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European Commission Approves Reduced Dosing Frequency for Janssen’s Bispecific Antibody TECVAYLI®▼ (teclistamab)
Teclistamab, the first BCMA-targeting bispecific antibody to receive approval in Europe, maintained deep and durable responses, with reduced onset of Grade 3 or higher infections, in eligible patients with relapsed and refractory multiple myeloma (RRMM) switching from weekly to reduced, biweekly dosing schedule.1,2
U.S. FDA Approves AKEEGA™ (Niraparib and Abiraterone Acetate), the First-And-Only Dual Action Tablet for the Treatment of Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer
Approval is based on the Phase 3 MAGNITUDE study, a prospectively designed precision medicine study including the largest population of BRCA-positive patients in combination trials to date with metastatic castration-resistant prostate cancer (mCRPC) AKEEGA™ plus prednisone significantly improved radiographic progression-free survival compared to abiraterone acetate plus prednisone (AAP) in patients with BRCA-positive mCRPC
U.S. FDA Approves TALVEY™ (talquetamab-tgvs), a First-in-Class Bispecific Therapy for the Treatment of Patients with Heavily Pretreated Multiple Myeloma
Bispecific antibody targeting GPRC5D receptor showed an overall response rate of more than 70 percent with durable responses, including in patients previously treated with a bispecific antibody or CAR-T cell therapy
Treatment with RYBREVANT® (amivantamab-vmjw) Plus Chemotherapy Resulted in Statistically Significant and Clinically Meaningful Improvement in Progression-Free Survival in Patients with Newly Diagnosed EGFR Exon 20 Insertion Mutation-Positive Non-Small Cell Lung Cancer
First Phase 3 study to demonstrate clinically meaningful results versus standard of care in a newly diagnosed exon 20 population, a patient population with high unmet medical need
Janssen Submits Supplemental Biologics License Application to U.S. FDA Seeking Approval of CARVYKTI® for the Earlier Treatment of Patients with Relapsed or Refractory Multiple Myeloma
Application is supported by data from the Phase 3 CARTITUDE-4 study, which showed significant improvement in primary endpoint of progression-free survival (PFS) CARTITUDE-4 is the first randomized Phase 3 study investigating the efficacy of a cell therapy as early as after first relapse in multiple myeloma
Janssen Presents Longer-Term Data for TECVAYLI® (teclistamab-cqyv) Showing a Duration of Response of 22 Months in Patients with Relapsed or Refractory Multiple Myeloma
More than 60 percent of patients achieved an overall response and 45.5 percent of patients achieved a complete response or better by nearly five months Additional data highlights strong efficacy with biweekly TECVAYLI® dosing and show strategies for improving cytokine release syndrome with prophylactic tocilizumab
Janssen Reports First Results from Phase 2 SunRISe-1 Study of TAR-200 and Anti- PD-1 Antibody Cetrelimab in Patients with Bacillus Calmette-Guérin-Unresponsive Non-Muscle-Invasive Bladder Cancer
Study results of novel drug-eluting technology highlight potential durability of TAR-200 in patient population with high unmet need
Janssen Marks First Approval Worldwide for AKEEGA® (Niraparib and Abiraterone Acetate Dual Action Tablet) with EC Authorization for the Treatment of Patients with Metastatic Castration Resistant Prostate Cancer with BRCA1/2 Mutations
Approval for AKEEGA® is based on results from the Phase 3 MAGNITUDE study, a prospectively designed precision medicine study that includes the largest cohort to date of BRCA1/2-positive patients with untreated metastatic castration-resistant prostate cancer (mCRPC).1,2 Niraparib in combination with abiraterone acetate (AA), plus prednisone or prednisolone, significantly improved radiographic progression-free survival (rPFS) compared to standard of care in untreated mCRPC patients with BRCA1/2 mutations.3
ERLEADA® (apalutamide), First-and-Only Next-Generation Androgen Receptor Inhibitor with Once-Daily, Single-Tablet Option, Now Available in the U.S.
Addition of 240mg strength allows prescribers flexibility to prescribe one 240mg tablet or four 60mg tablets once-daily based on patient needs
Janssen Submits New Drug Application to the U.S. Food and Drug Administration Seeking Approval of Niraparib and Abiraterone Acetate Dual-Action Tablet, Plus Prednisone, as a First-Line Targeted Treatment for Patients with Metastatic Castration-Resistant Prostate Cancer with BRCA Gene Mutations
Niraparib and Abiraterone Acetate Plus Prednisone Has Potential to Address Unmet Need for Patients with BRCA-Positive mCRPC
Janssen Receives Positive CHMP Opinion for AKEEGA® (Niraparib and Abiraterone Acetate Dual Action Tablet) Plus Prednisone or Prednisolone for the Treatment of Adult Patients with BRCA1/2 Gene-Mutated Metastatic Castration Resistant Prostate Cancer
If approved, niraparib in combination with abiraterone acetate (AA), will be the first dual action tablet (DAT) available in the European Union for first-line treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) with BRCA1/2 mutations, when given with prednisone (P) or prednisolone.[i] The positive CHMP opinion is based on results from the Phase 3 MAGNITUDE study where the addition of niraparib to AA plus P significantly improved radiographic progression-free survival (rPFS) compared to standard of care in untreated mCRPC patients with BRCA1/2 mutations.[ii]
Janssen Presents Updated Data Demonstrating Improved Outcomes from the Use of Niraparib in Combination with Abiraterone Acetate Plus Prednisone as a First-Line Therapy in Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer
Results from the Phase 3 MAGNITUDE study second interim analysis to be featured in an oral presentation at ASCO GU
Janssen Data at ASCO GU Support Ambition to Transform Treatment of Prostate and Bladder Cancer Through Precision Medicine and Early Intervention
Updated data from the Phase 3 MAGNITUDE study of niraparib in combination with abiraterone acetate plus prednisone in patients with metastatic castration-resistant prostate cancer will be featured
Janssen Announces Unblinding of Phase 3 CARTITUDE-4 Study of CARVYKTI® (cilta-cel) as Primary Endpoint Met in Treatment of Patients with Relapsed and Refractory Multiple Myeloma
Study unblinded following recommendation of Independent Data Monitoring Committee
Real-World Study Shows Patients Treated with IMBRUVICA® (ibrutinib) Were Less Likely to Initiate a Next-Line Treatment than Patients on Acalabrutinib in First-line Chronic Lymphocytic Leukemia
More than two years of electronic medical records indicate patients were 89 percent more likely to start a next-line treatment when on acalabrutinib versus IMBRUVICA®
Janssen Presents Efficacy and Subgroup Analyses from MAIA Study Showing Long-Term Results of DARZALEX® (daratumumab)-based Regimen in Newly Diagnosed, Transplant-Ineligible Multiple Myeloma
Updated analyses report on progression-free survival, minimal residual disease negativity, overall response and overall survival across patient types, regardless of age or cytogenetic risk Five-year follow-up highlights health-related quality of life data in a subgroup of frail patients
