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European Commission approves Johnson & Johnson’s subcutaneous DARZALEX® (daratumumab)-based quadruplet regimen for the treatment of patients with newly diagnosed multiple myeloma, regardless of transplant eligibility

Approval cements daratumumab as a foundational therapy in newly diagnosed multiple myeloma and the only anti-CD38 antibody for all patient types in this setting Phase 3 CEPHEUS study shows significant improvement in minimal residual disease (MRD)-negativity rate,progression-free survival and complete response or better versus standard of care1

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European Commission approves subcutaneous RYBREVANT®▼ (amivantamab) for the treatment of patients with advanced EGFR-mutated non-small cell lung cancer

Subcutaneous (SC) amivantamab offers patients greater convenience, reducing administration time from hours to minutes and with a five-fold reduction in infusion-related reactions compared to the IV formulation1 European Commission (EC) approval based on positive results from the Phase 3 PALOMA-3 study1

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European Commission approves STELARA® (ustekinumab) for the treatment of moderately to severely active Crohn’s disease in paediatric patients

Ustekinumab is now approved for the treatment of moderately to severely active Crohn’s disease in paediatric patients, in addition to existing indications including adult and paediatric plaque psoriasis, and psoriatic arthritis, ulcerative colitis and Crohn’s disease in adult patients1,2

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TREMFYA® (guselkumab) receives positive CHMP opinion for treatment of patients with moderately to severely active Crohn’s Disease

Recommendation based on the findings from the Phase 3 studies (GALAXI programme and GRAVITI) in Crohn’s disease1,2,3

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Enhanced preventive regimen demonstrates a statistically significant and clinically meaningful reduction in dermatologic reactions in patients with EGFR-mutated advanced NSCLC

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RYBREVANT®▼ (amivantamab) plus LAZCLUZE®▼ (lazertinib) demonstrates significant overall survival benefit in patients with EGFR-mutated advanced non-small cell lung cancer versus osimertinib

Median overall survival not yet reached with a projected improvement of more than one year versus osimertinib*1

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Icotrokinra results show potential to set a new standard of treatment in plaque psoriasis

Combination of complete skin clearance data and favourable safety profile in a once daily pill could shift treatment paradigm Nearly half of patients with moderate-to-severe plaque psoriasis (Pso) treated with investigational icotrokinra achieved completely clear skin (IGA 0) at Week 24 in ICONIC-LEAD Topline results from Phase 3 ICONIC-ADVANCE 1&2 studies show icotrokinra achieved co-primary endpoints and showed superiority to deucravacitinib in moderate-to-severe plaque Pso These results pave the way to initiate the first-ever head-to-head study seeking to demonstrate the superiority of a pill versus injectable biologic in moderate-to-severe plaque Pso

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Johnson & Johnson’s DARZALEX® (daratumumab) subcutaneous-based regimen receives positive CHMP opinion for patients with newly diagnosed multiple myeloma, regardless of transplant eligibility

If approved, daratumumab will be the only anti-CD38 available for all patient types across newly diagnosed multiple myeloma, cementing daratumumab as a foundational therapy in the frontline setting. Recommendation supported by results from CEPHEUS, the fifth Phase 3 study of daratumumab to demonstrate improved progression free survival in the frontline setting.1,2,3,4

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