Innovative Medicine
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Johnson & Johnson’s RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) receives U.S. FDA Priority Review as potential first-in-class EGFR- and MET-targeted subcutaneous treatment for advanced head and neck cancer
Priority Review reinforces the significant potential of subcutaneous amivantamab in recurrent or metastatic head and neck cancer, where the current five-year survival rate is only 15 percent Patients achieved rapid, deep and durable responses, including a 42 percent overall response rate with one-third achieving a complete response Subcutaneous amivantamab is the only therapy in head and neck cancer engineered to target both EGFR and MET, proven drivers of tumor growth and treatment resistance -
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TECVAYLI® + TALVEY® reduced the risk of disease progression or death by 89% and the risk of death by 62% in earlier-line relapsed/refractory multiple myeloma
· Investigational MonumenTAL-6 trial is the first and only Phase 3 study of a dual antigen, BCMA and GPRC5D targeting regimen in relapsed/refractory multiple myeloma · Fifth positive Phase 3 study evaluating Johnson & Johnson’s multiple myeloma T-cell therapy portfolio in second line, further strengthening the company’s leadership and commitment to advancing immunotherapy-based regimens earlier in the treatment journey -
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IMAAVY® (nipocalimab-aahu) demonstrates durable hemoglobin response and rapid onset of effect in pivotal Phase 2/3 study in warm autoimmune hemolytic anemia (wAIHA), an autoantibody-driven disease with no FDA-approved therapies
· Patients in the IMAAVY 30 mg/kg treatment groupa achieved statistically significant durable hemoglobin responseb, with mean hemoglobin improvement of at least 1 g/dL as early as Week 1c · More patients treated with IMAAVY experienced improvement in fatigued and corticosteroid dose reductionse · IMAAVY is designed to target pathogenic immunoglobulin G (IgG) autoantibodies in warm autoimmune hemolytic anemia while preserving immune function · Pivotal results will be presented at EHA 2026 -
Johnson & Johnson to Acquire Firefly Bio, Inc. to Expand Oncology Pipeline with Novel Degrader Antibody Conjugate Platform
• Expands the Company’s expertise in targeting pan-KRAS and other drivers of hard-to-treat cancers • Acquisition adds a proprietary degrader antibody conjugate platform designed to overcome key limitations of existing therapeutic approaches • Strengthens leadership in next-generation antibody engineering to accelerate oncology innovation -
Johnson & Johnson late-breaking results show nipocalimab significantly reduced systemic lupus erythematosus (SLE) disease activity in a Phase 2 study
· Nipocalimab – the first and only neonatal Fc receptor (FcRn) blocker to be studied in systemic lupus erythematosus – is designed to target and reduce pathogenic immunoglobulin G (IgG) autoantibodies associated with this disease while preserving immune function · Results demonstrated significant reduction of systemic lupus erythematosus disease activity which continued beyond the 24-week primary endpoint, and were sustained through Week 52 in the nipocalimab 15 mg/kg groupa · The ongoing Phase 3 study of nipocalimab is currently recruiting people living with systemic lupus erythematosus – a debilitating autoantibody-driven disease which can lead to systemic organ damage -
Johnson & Johnson presents new data further reinforcing the role of nipocalimab in lowering the autoantibodies driving Sjögren’s disease
· Nipocalimab, an immunoselective neonatal Fc receptor (FcRn) blocker, is designed to target and reduce pathogenic immunoglobulin G (IgG) autoantibodies associated with Sjögren’s disease while preserving immune function · New exploratory analysis of Phase 2 study data shows a strong correlation between autoantibody levels and even greater clinical response rates of participants in the nipocalimab treatment group · Previously reported data from the Phase 2 study showed nipocalimab reduced Sjögren’s disease activity and severity, with potential to address systemic manifestations and the most burdensome patient-reported symptoms including dryness, fatigue and pain · Nipocalimab is the only FcRn blocker granted both Breakthrough Therapy Designation and Fast Track Designation by the U.S. FDA for the treatment of adults with moderate-to-severe Sjögren’s disease.