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European Commission approves IMBRUVICA® (ibrutinib) as the first targeted therapy for patients with previously untreated mantle cell lymphoma who would be eligible for autologous stem cell transplant

Ibrutinib is the first approved Bruton’s tyrosine kinase (BTK) inhibitor to demonstrate statistically meaningful outcomes versus autologous stem cell transplant (ASCT) for the frontline treatment of transplant eligible patients with mantle cell lymphoma1 Data from the Phase 3 TRIANGLE study defines the fixed-duration ibrutinib-based regimen as a new standard of care (SOC) with significantly improved overall survival and failure-free survival versus ASCT1

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Johnson & Johnson submits application to the European Medicines Agency seeking indication extension of AKEEGA® (niraparib and abiraterone acetate dual action tablet) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer and HRR gene alterations

The submission is based on results from the Phase 3 AMPLITUDE study evaluating niraparib in combination with abiraterone acetate plus prednisone or prednisolone compared to a current standard of care, abiraterone acetate plus prednisone or prednisolone1 The results demonstrate significant and clinically meaningful benefits of the niraparib and abiraterone acetate plus prednisone or prednisolone regimen in delaying cancer progression and worsening of symptoms1

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Nipocalimab showed greater sustained disease control versus approved FcRn blockers for generalised myasthenia gravis (gMG) at multiple timepoints over 24 weeks in newly published indirect treatment comparison (ITC)

The ITC compared all published Phase 3 data of these treatments, leveraging longitudinal results, and findings reinforce the importance of consistent, sustained disease control in managing a chronic autoantibody disease like gMG IMAAVY (nipocalimab), an FcRn blocker, received U.S. FDA approval earlier this year for the broad population of individuals living with gMG, including anti-AChR and anti-MuSK antibody positive adults and paediatric gMG patients aged 12 and older

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DARZALEX® (daratumumab) receives the first positive CHMP opinion for patients with high-risk smouldering multiple myeloma

If approved, daratumumab will be the first authorised treatment option for patients with smouldering multiple myeloma at high-risk of developing multiple myeloma, offering the potential for disease interception1 Recommendation backed by results from the Phase 3 AQUILA study, which demonstrate that daratumumab has the potential to significantly delay the onset of myeloma and the need for treatment, as well as to extend overall survival2

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IMBRUVICA® (ibrutinib) receives positive CHMP opinion for the treatment of patients with previously untreated mantle cell lymphoma (MCL) who would be eligible for autologous stem cell transplant 

Pending the European Commission final decision, regimen offers a new standard of care for eligible MCL patients1,2 Positive opinion reinforces Phase 3 TRIANGLE study results by the European MCL Network, showing ibrutinib plus chemotherapy delivers significantly improved overall survival without the burden of transplant1,2

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Investigational combination of first-in-class bispecific antibodies TALVEY®▼ (talquetamab) and TECVAYLI®▼ (teclistamab) shows deep and durable responses in heavily pretreated multiple myeloma patients with extramedullary disease

Results from the Phase 2 RedirecTT-1 study demonstrate deep responses with 78.9 percent overall response rate through dual targeting of GPRC5D and BCMA1 Data signal potential of novel, off-the-shelf approach in patients with extramedullary disease who face significant unmet needs1 

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Significant efficacy benefit of IMBRUVICA® (ibrutinib) plus venetoclax versus acalabrutinib plus venetoclax in frontline treatment of patients with chronic lymphocytic leukaemia suggested by indirect treatment comparison

Cross-study findings indicate significant clinical benefit of frontline fixed-duration ibrutinib plus venetoclax with improved likelihood of undetectable minimal residual disease and progression-free survival versus acalabrutinib plus venetoclax1 Phase 2 CAPTIVATE long-term follow-up data further supports sustained efficacy and safety profile of fixed-duration ibrutinib plus venetoclax treatment in patients receiving frontline treatment for chronic lymphocytic leukaemia2

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New data show TREMFYA® (guselkumab) is the only IL-23 inhibitor proven to significantly inhibit progression of joint damage in active psoriatic arthritis

TREMFYA ® (guselkumab) demonstrated two and a half times greater ability to inhibit structural damage versus placebo in the Phase 3b APEX study1 More than 40% of guselkumab-treated patients across both dose groups achieved ACR50 at Week 241 Improvement in both joint and skin symptoms reinforce guselkumab as a first-line treatment option with an established efficacy and safety profile for adults with active psoriatic arthritis1

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Johnson & Johnson’s AKEEGA® (niraparib and abiraterone acetate dual-action tablet) is the first PARP inhibitor combo to show improved efficacy in patients with HRR-mutated mHSPC vs. current standard of care

Results from the Phase 3 AMPLITUDE study show the potential of niraparib and abiraterone acetate to delay cancer progression and worsening of symptoms1 Data show a nearly 50 percent reduction in disease progression in BRCA-altered mHSPC1

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New analyses reinforce long-term benefit of DARZALEX® (daratumumab) subcutaneous-based quadruplet regimen for patients with newly diagnosed multiple myeloma

Sustained MRD negativity (10-5) rates at 24 months or longer were more than doubled in transplant eligible patients treated with daratumumab-VRd vs VRd alone in the Phase 3 PERSEUS study1 Data from the Phase 3 CEPHEUS study show daratumumab-VRd significantly reduced the risk of progression or death by 49 percent vs VRd alone in transplant-ineligible newly diagnosed patients2

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