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TREMFYA® (guselkumab) subcutaneous (SC) induction data support the potential to be the first in its class to offer the option of both intravenous (IV) and SC induction therapy in ulcerative colitis

Newsroom

Johnson & Johnson submits application to the European Medicines Agency for first paediatric indication for TREMFYA® (guselkumab)

Newsroom

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

Newsroom

Findings from pivotal nipocalimab Phase 3 study in a broad antibody positive population of people living with generalised myasthenia gravis published in The Lancet Neurology

The first investigational FcRn blocker to demonstrate sustained disease control over 24 weeks in antibody positive adult patients: anti-AChR+, anti-MuSK+, anti-LRP4+ Nipocalimab demonstrated a sustained reduction in autoantibody levels, one of the underlying causes of generalised myasthenia gravis (gMG), by up to 75% over a period of 24 weeks The investigational therapy was recently granted U.S. FDA Priority Review for the treatment of gMG

Newsroom

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

Oncology

European Commission approves RYBREVANT®▼ (amivantamab) in combination with LAZCLUZE®▼ (lazertinib) for the first-line treatment of patients with EGFR-mutated advanced non-small cell lung cancer

This multitargeted, chemotherapy-free combination demonstrated superiority over osimertinib monotherapy for the first-line treatment of patients with EGFR-mutated NSCLC1 In the Phase 3 MARIPOSA study, amivantamab plus lazertinib significantly reduced the risk of disease progression or death by 30 percent versus osimertinib monotherapy1

Oncology

Johnson & Johnson submits application to the European Medicines Agency seeking approval of a new indication for IMBRUVICA® (ibrutinib) in adult patients with previously untreated mantle cell lymphoma (MCL) who are eligible for autologous stem cell transplant

The European MCL Network Phase 3 TRIANGLE study, evaluated ibrutinib in combination with induction immunochemotherapy, both with and without an autologous stem cell transplant, followed by 24 months fixed- duration ibrutinib therapy1 Both ibrutinib-based regimens, transplant-free and with transplant, delivered clinically meaningful improvement in efficacy compared to the current standard of care of induction immunochemotherapy followed by transplant2

Immunology

Results published in The Lancet show TREMFYA® (guselkumab) achieved robust induction and maintenance effects in ulcerative colitis, with clinically meaningful improvements across clinical, endoscopic, histologic, symptomatic and patient-reported outcomes

In both QUASAR induction and maintenance studies, significantly greater proportions of patients with ulcerative colitis achieved clinical remission with guselkumab at Week 12 after receiving intravenous induction therapy and Week 44 of maintenance therapy versus placebo.1

Oncology

CARVYKTI®▼ (ciltacabtagene autoleucel; cilta-cel) demonstrated significantly higher rates of minimal residual disease negativity compared to standard therapies in the CARTITUDE-4 study

89 percent of patients evaluable for minimal residual disease (MRD) assessment were MRD negative, with the majority reaching MRD negativity in less than 2 months1 Results add to the overall survival (OS) benefits recently presented, as the first cell therapy to significantly extend OS versus standard therapies in multiple myeloma1,2

Oncology

DARZALEX® (daratumumab) SC-based regimens improve MRD negativity and progression-free survival in newly diagnosed multiple myeloma, and overall survival in AL amyloidosis

New analysis from Phase 3 CEPHEUS study demonstrates 85 percent of patients who achieved MRD negativity (10-6) with daratumumab SC were progression free at 4.5 years1 AURIGA study shows higher rates of MRD negative conversion in subgroup patient populations disproportionately impacted by multiple myeloma2 Final analysis of Phase 3 ANDROMEDA study shows the addition of daratumumab to VCd significantly improves overall survival for patients with newly diagnosed AL amyloidosis3

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