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European Commission approves AKEEGA® (niraparib and abiraterone acetate dual action tablet) for the treatment of patients with BRCA1/2-mutated metastatic hormone-sensitive prostate cancer (mHSPC)

Niraparib and abiraterone acetate regimen demonstrates clinically meaningful delay in disease progression, nearly halving the risk of progression or death, with an early trend toward improved overall survival versus standard of care1 Approximately one in ten patients with mHSPC harbour BRCA1/2 alterations, reinforcing the need for new targeted treatment options2 Expanded indication for niraparib and abiraterone acetate delivers a precision-based treatment approach for this patient population1

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Subcutaneous RYBREVANT®▼ (amivantamab) approved by European Commission for every-three-week and every-four-week dosing for patients with advanced EGFR-mutated non-small cell lung cancer

Subcutaneous (SC) amivantamab reduces administration from hours to minutes, with efficacy and safety consistent with intravenous (IV) amivantamab1,2,3,4,5 SC amivantamab is now authorised across all previously approved IV indications, offering fewer administration-related reactions and new dosing options1,2,3,4,5,6

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TREMFYA® (guselkumab) long-term data show sustained clinical and endoscopic remission in ulcerative colitis through 3 years

At Week 140 of the QUASAR long-term extension (LTE) study, both TREMFYA® (guselkumab) dosing schedules (100mg every 8 weeks [GUS100) and 200mg every 4 weeks [GUS200]) demonstrated: • Clinical remission in more than 80% of patients • Endoscopic remission (normalisation) MES of 0 in more than 50% of patients • Histo-endoscopic mucosal improvement in 78% of patients (intestinal healing at both the tissue and visual level)

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Johnson & Johnson receives CHMP positive opinion for AKEEGA® (niraparib and abiraterone acetate dual action tablet) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) with BRCA1/2 mutations

AMPLITUDE is the first clinical trial to evaluate potential therapies for patients with mHSPC and known HRR gene alterations, with positive results supporting the niraparib-based combination regimen as a new standard of care for patients with BRCA mutations1 Results demonstrate a delay in disease progression and an early trend toward improved overall survival with the niraparib and abiraterone acetate regimen versus standard of care in the treatment of mHSPC1

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Johnson & Johnson submits application to the European Medicines Agency for TECVAYLI®▼ (teclistamab) in combination with DARZALEX® (daratumumab) subcutaneous formulation for patients with relapsed/refractory multiple myeloma

Novel immunotherapy combination regimen brings together two complementary therapies to improve outcomes for people living with multiple myeloma as early as second line1 The application is supported by data from the Phase 3 MajesTEC-3 study demonstrating a statistically significant improvement in progression-free and overall survival compared to standard treatment1

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European Commission approves TREMFYA® (guselkumab) for the treatment of children with plaque psoriasis, marking the first paediatric indication for an IL-23 inhibitor

Guselkumab has received approval for moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy.1 The decision is supported by the Phase 3 PROTOSTAR study, where guselkumab demonstrated higher levels of skin clearance vs. placebo at Week 16.2

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Unprecedented results from the Phase 3 MajesTEC-3 study support TECVAYLI®▼ (teclistamab) plus DARZALEX® (daratumumab) subcutaneous formulation as a potential standard of care as early as second line for patients with relapsed/refractory multiple myeloma

Teclistamab and daratumumab subcutaneous (SC) combination led to a statistically significant progression-free survival and overall survival advantage compared to standard treatment after three years of follow-up1 Combination regimen granted Breakthrough Therapy Designation by U.S. FDA

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Earlier use of CARVYKTI®▼ (ciltacabtagene autoleucel) demonstrated lasting treatment-free remissions at 2.5 years in patients with relapsed or refractory multiple myeloma

Follow-up data from CARTITUDE-4 show at least 80 percent of as-treated standard-risk patients remained progression- and treatment-free following a single infusion as early as second line1 Data suggest stronger immune fitness in earlier lines may be associated with longer progression-free survival2

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Johnson & Johnson receives European Commission approval of IMAAVY®▼ (nipocalimab), a new FcRn blocker offering sustained disease control in a broad population of people living with generalised myasthenia gravis (gMG)

Nipocalimab is the first FcRn blocker approved in both adult and adolescent gMG patients aged 12 and older who are anti-AChR or anti-MuSK antibody-positive In the pivotal Phase 3 Vivacity-MG3 and Phase 2/3 Vibrance-MG studies over 24 weeks, nipocalimab demonstrated rapid and substantial reduction in immunoglobulin G levels, one of the root causes of gMG gMG patients taking nipocalimab demonstrated up to 20 months of sustained disease control and symptom relief in the Vivacity-MG3 study and ongoing open-label extension

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TREMFYA® (guselkumab) receives European Commission approval for subcutaneous induction through to maintenance in adults with ulcerative colitis, now the first IL-23 inhibitor with a fully subcutaneous dose regimen

Guselkumab offers the flexibility of self-administration from the start of treatment in both ulcerative colitis (UC) and Crohn’s disease (CD),1,2,3 providing the simplicity of a fully subcutaneous dose regimen in both diseases2,4 Guselkumab achieved significant rates of clinical remissiona and endoscopic healingb versus placebo at Week 12 with a subcutaneous induction dose regimen in UC,2,5 consistent with intravenous induction2,6

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