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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

December 18, 2024

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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

December 18, 2024

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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 myeloma^1,2

December 10, 2024

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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

December 9, 2024

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Oncology

TECVAYLI®▼ (teclistamab) demonstrates potential as frontline combination therapy for patients with newly diagnosed multiple myeloma

100 percent of evaluable patients for minimal residual disease (MRD) testing achieved MRD negativity in MajesTEC-5 as induction therapy and MajesTEC-4 as maintenance therapy^1,2

December 8, 2024

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Oncology

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 extend progression-free survival and overall survival based on findings from Phase 3 AQUILA study¹

December 8, 2024

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Oncology

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 mutations¹

In the Phase 3 MARIPOSA study, amivantamab plus lazertinib significantly reduced risk of disease progression or death by 30 percent versus osimertinib monotherapy¹

November 15, 2024

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Immunology

Nipocalimab demonstrates significant clinical improvement in disease activity and IgG reduction in Phase 2 Sjögren’s disease study

Adults with moderately-to-severely active Sjögren’s disease who received investigational FcRn blocker, nipocalimab, had improvements in disease activity scores at 24 weeks with accompanying significant reductions in IgG and autoantibody levels

Nipocalimab was granted U.S. FDA Breakthrough Therapy Designation for the treatment of adults living with moderate-to-severe Sjögren’s disease based on results from the Phase 2 DAHLIAS study

November 14, 2024

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