Johnson & Johnson Innovative Medicine
Pharmaceutical Companies of Johnson and Johnson
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 26 March 2025 -- Beerse, Belgium -- Janssen-Cilag International NV, a Johnson & Johnson company, today announced results for the gold standard endpoint in cancer treatment of overall survival (OS) from the Phase 3 MARIPOSA study. Head-to-head comparison...
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...
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 events CHMP has issued a positive opinion for an extension of marketing authorisation for subcutaneous amivantamab dosed every two weeks 3 February 2025 --...
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 osimertinib Median overall survival improvement is expected to exceed one year. 21 January 2025 -- Beerse, Belgium -- Janssen-Cilag International NV, a Johnson & Johnson company,...
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 therapy 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...
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 extendprogression-free survival and overall survival based on findings from Phase 3 AQUILA study 8 December 2024 – BEERSE, BELGIUM – Janssen-Cilag International NV, a Johnson & Johnson company, today announced data from the Phase 3 AQUILA study showing that DARZALEX® (daratumumab) subcutaneous (SC)...
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 mutations In the Phase 3 MARIPOSA study, amivantamab plus lazertinib significantly reduced risk of disease progression or death by 30 percent versus osimertinib monotherapy 15 November...
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 damage 6 November 2024 -- Beerse, Belgium -- Janssen-Cilag International NV, a Johnson & Johnson company,...
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 death New regimen reinforces daratumumab SC as a foundational element for optimising frontline treatment of patients with newly...
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 15 October 2024 -- Beerse, Belgium -- Janssen-Cilag International NV, a Johnson & Johnson company, today announced positive results from the Phase 2/3 Vibrance-MG study of...
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