EMEA Search Results

Oncology

TECVAYLI®▼ (teclistamab) 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 therapy1,2

Oncology

DARZALEX® (daratumumab) subcutaneous formulation shows 51 percent reduction in risk of progression to active multiple myeloma for patients with high-risk smouldering multiple myeloma

First subcutaneous anti-CD38 therapy to demonstrate potential to prevent end-organ damage, and extend progression-free survival and overall survival based on findings from Phase 3 AQUILA study1

Oncology

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

Immunology

Nipocalimab demonstrates significant clinical improvement in disease activity and IgG reduction in Phase 2 Sjögren’s disease study

Adults with moderately-to-severely active Sjögren’s disease who received investigational FcRn blocker, nipocalimab, had improvements in disease activity scores at 24 weeks with accompanying significant reductions in IgG and autoantibody levels Nipocalimab was granted U.S. FDA Breakthrough Therapy Designation for the treatment of adults living with moderate-to-severe Sjögren’s disease based on results from the Phase 2 DAHLIAS study

Oncology

Johnson & Johnson submits applications in the U.S. and EU seeking approval of DARZALEX FASPRO®/DARZALEX® (daratumumab) as subcutaneous monotherapy for high-risk smouldering multiple myeloma

If approved, daratumumab will become the first treatment option for patients with smouldering 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 damage1

Immunology

TREMFYA® (guselkumab) is the first IL-23 inhibitor to demonstrate robust results with a fully subcutaneous regimen in both induction and maintenance in Crohn’s disease

A greater number of patients treated with subcutaneous TREMFYA® induction and maintenance achieved clinical and endoscopic remission at 48 weeks in the Phase 3 GRAVITI study versus placebo1 TREMFYA® could become the first IL-23 treatment to offer both a subcutaneous and intravenous induction regimen for patients living with Crohn’s disease1

Oncology

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

Immunology

Nipocalimab demonstrates sustained disease control in adolescents living with generalised myasthenia gravis in the Phase 2/3 study

First FcRn blocker to demonstrate sustained disease control over 24 weeks in antibody positive adolescents aged 12 – 17 years, broadening the population in which nipocalimab has been studied

Immunology

New post-hoc analysis pooling two clinical trials demonstrates endoscopic response as a predictor of positive long-term patient outcomes in Crohn’s disease, including clinical remission and improved quality of life

Pooled data for guselkumab and ustekinumab in moderate-to severe Crohn’s disease demonstrated a higher percentage of patients with endoscopic response at year 1 achieved long-term response and remission at year 2 vs patients with no endoscopic response.1

Immunology

TREMFYA® (guselkumab) demonstrates robust results across biologic-naïve and biologic-refractory patients in Crohn’s disease and ulcerative colitis

Guselkumab is the only IL-23 inhibitor to demonstrate superiority to ustekinumab in the overall population of people living with Crohn’s disease, inclusive of those who are biologic-naïve and biologic-refractory 1 Ninety percent more biologic-naïve patients and three times more biologic-refractory patients living with ulcerative colitis achieved endoscopic remission with guselkumab compared to placebo 2

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