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Janssen Announces Treatment with ERLEADA® (apalutamide) Significantly Improved Overall Survival in Patients with Metastatic Castration-Sensitive Prostate Cancer
Final analysis from Phase 3 TITAN study demonstrated ERLEADA® provided statistically significant overall survival benefit and consistent safety profile in patients with advanced prostate cancer, regardless of extent of disease
Janssen Presents Results from Phase 3 ACIS Study in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with ERLEADA® (apalutamide) and ZYTIGA® (abiraterone acetate) Combination
ACIS study meets primary endpoint of improving time to radiographic progression or death in patients with advanced disease
SPRAVATO® (Esketamine Nasal Spray) Authorised in Europe for the Rapid Reduction of Depressive Symptoms in a Psychiatric Emergency for Patients with Major Depressive Disorder
· This milestone makes esketamine nasal spray the first N-methyl-D-aspartate (NMDA) antagonist to be approved for patients with Major Depressive Disorder (MDD) in a psychiatric emergency1–3 · European Commission (EC) authorisation is based on results from two Phase 3 ASPIRE studies, which evaluated the efficacy and safety of esketamine nasal spray used in addition to comprehensive standard of care (SOC)4–6 · This authorisation marks the second indication for esketamine nasal spray in the European Economic Area (EEA)7
Johnson & Johnson Announces Submission of Application to the U.S. FDA for Emergency Use Authorization of its Investigational Single-Shot Janssen COVID-19 Vaccine Candidate
Johnson & Johnson intends to distribute vaccine to the U.S. government immediately following authorization, and expects to supply 100 million doses to the U.S. in the first half of 2021
Janssen Announces U.S. FDA Approval of CABENUVA (rilpivirine and cabotegravir), the First Long-Acting Regimen for the Treatment of HIV
CABENUVA offers adults living with HIV a new once-monthly injectable option for maintaining viral suppression
New Data Demonstrate Long-Term Benefit of IMBRUVICA® (ibrutinib) as First-Line Treatment for High-Risk Chronic Lymphocytic Leukemia
IMBRUVICA® pooled clinical trial analyses presented at ASH demonstrate sustained efficacy and safety in patients with historically poor outcomes Data from real-world evidence studies featured as oral presentations highlight the benefit of IMBRUVICA®-based therapies in the first-line setting
Janssen Presents First Data from the Phase 1 Study of the GPRC5DxCD3 Bispecific Talquetamab in Patients with Relapsed or Refractory Multiple Myeloma
Data presented at ASH 2020 for first-in-class talquetamab support recommended Phase 2 dose with subcutaneous formulation
Disease-Free Survival Data from CAPTIVATE Study Demonstrate Benefit of IMBRUVICA® (ibrutinib)-Based Regimen as Fixed Duration, First-Line Treatment for Patients with Chronic Lymphocytic Leukemia
New data from the double-blind, placebo-controlled, randomized phase of the Phase 2 CAPTIVATE study presented at ASH 2020 showed that 95 percent of patients with undetectable minimal residual disease randomized to discontinue active treatment after twelve cycles of treatment with IMBRUVICA® plus venetoclax were disease-free and alive, supporting a fixed duration treatment approach