EMEA Search Results

Oncology

RYBREVANT®▼ (amivantamab) plus lazertinib shows longer progressionfree survival versus osimertinib in the first-line treatment of patients with high-risk EGFR-mutated non-small cell lung cancer

Investigational chemotherapy-free regimen of amivantamab plus lazertinib addresses a significant unmet need as most patients with EGFR-mutated NSCLC have high-risk disease1 Landmark Phase 3 MARIPOSA data featured in an oral presentation at ASCO1

Oncology

Johnson & Johnson submits application to the European Medicines Agency seeking approval of subcutaneous formulation of RYBREVANT®▼ (amivantamab) for the treatment of patients with EGFR-mutated non-small cell lung cancer

Submission is supported by data from the Phase 3 PALOMA-3 study featured at the American Society of Clinical Oncology (ASCO) Annual Meeting1 New formulation showed non-inferiority to intravenous administration in fourth positive Phase 3 amivantamab study1 Longer overall survival, progression-free survival and duration of response shown with subcutaneous amivantamab; featured in Best of ASCO 20241

Immunology

TREMFYA® (guselkumab) demonstrates superior efficacy versus STELARA® (ustekinumab) in first Phase 3 pooled data from two double-blind, placebo and active-controlled studies in Crohn’s disease

Data featured in late-breaking oral presentation at Digestive Disease Week (DDW) 2024, taking place in Washington DC from May 18-21, showed guselkumab successfully met the co-primary endpoints for both doses compared to ustekinumab in Phase 3 studies (GALAXI 2 and 3) while also meeting major secondary endpoints

Immunology

In new ulcerative colitis data from the Phase 3 QUASAR Maintenance Study, TREMFYA® (guselkumab) achieves the primary endpoint and all nine major secondary endpoints, including endoscopic normalisation and histo-endoscopic mucosal improvement

Data from this study support the TREMFYA® Regulatory Application submitted to the European Medicines Agency and the supplemental Biologics License Application (sBLA) currently under review by U.S. Food and Drug Administration (FDA)

Oncology

TAR-210 results show 90 percent recurrence-free survival and 90 percent complete response in patients with high-risk and intermediate-risk non-muscle-invasive bladder cancer, respectively

Updated results reinforce the potential of TAR-210 to transform treatment of non-muscle-invasive bladder cancer with fibroblast growth factor receptor (FGFR) alterations1

Oncology

TAR-200 monotherapy shows greater than 80 percent complete response rate in patients with high-risk non-muscle-invasive bladder cancer

New data from Phase 2b SunRISe-1 study show rapid achievement of complete response (CR) with 98 percent achieving a CR within 12 weeks1 TAR-200 provides durable CRs in patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk nonmuscle invasive bladder cancer (HR-NMIBC) with carcinoma in situ – a disease area with limited treatment options for patients1

Oncology

Phase 2 data for ERLEADA® ▼(apalutamide) plus androgen deprivation therapy following radical prostatectomy in patients with high-risk localised prostate cancer show 100 percent biochemical free recurrence rate more than two years post-surgery

Study highlights opportunity for treatment intensification in this population since approximately 50 percent of patients with high-risk localised prostate cancer (HRLPC) experience disease recurrence within two years of surgery1

Johnson & Johnson submits regulatory applications to European Medicines Agency for TREMFYA® (guselkumab) for treatment of patients with ulcerative colitis and Crohn’s disease

Submission included data from the Phase 3 QUASAR program in ulcerative colitis and the Phase 3 GALAXI program in Crohn’s disease, which each achieved their primary endpoints1,2

Oncology

Johnson & Johnson receives positive CHMP opinion for RYBREVANT®▼ (amivantamab) in combination with chemotherapy for the first-line treatment of patients with advanced non-small cell lung cancer with activating EGFR exon 20 insertion mutations

This positive CHMP opinion establishes amivantamab as a new option, and the first fully-human EGFR-MET bispecific antibody, in the first-line treatment of EGFR exon 20 insertion-mutated NSCLC The recommendation is supported by data from the Phase 3 PAPILLON study, which showed amivantamab plus chemotherapy significantly improved progression-free survival in adult patients, versus chemotherapy alone1

Oncology

CARVYKTI®▼ (ciltacabtagene autoleucel; cilta-cel) is the first BCMA-targeted treatment approved by the European Commission for patients with relapsed and refractory multiple myeloma who have received at least one prior line of therapy

Expanded indication for this one-time infusion may provide patients with a potential period away from their multiple myeloma treatment as early as first relapse1 Approval is based on results from the PHASE 3 CARTITUDE-4 study, in which treatment with cilta-cel in 1-3 prior lines of therapy reduced the risk of disease progression or death by 74 percent compared to standard therapies1

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