Guselkumab 100 mg/1 mL solution for injection in pre-filled pen (PushPen) expands administration options and continuity of care,1,2 offering a spring-loaded, fully automated injection with built-in safety mechanism,2 helping to reduce needle accidents and consequently administration anxiety.2,3

Landmark approval is based on results from the Phase 3 AQUILA study, showing fixed-duration treatment with daratumumab significantly reduced the risk of progression to active multiple myeloma or death by 51 percent compared to active monitoring1 This milestone marks a critical advance in early intervention for multiple myeloma as the first authorised treatment, offering a new treatment paradigm for patients with high-risk smouldering disease2

Ibrutinib is the first approved Bruton’s tyrosine kinase (BTK) inhibitor to demonstrate statistically meaningful outcomes versus autologous stem cell transplant (ASCT) for the frontline treatment of transplant eligible patients with mantle cell lymphoma1 Data from the Phase 3 TRIANGLE study defines the fixed-duration ibrutinib-based regimen as a new standard of care (SOC) with significantly improved overall survival and failure-free survival versus ASCT1

The submission is based on results from the Phase 3 AMPLITUDE study evaluating niraparib in combination with abiraterone acetate plus prednisone or prednisolone compared to a current standard of care, abiraterone acetate plus prednisone or prednisolone1 The results demonstrate significant and clinically meaningful benefits of the niraparib and abiraterone acetate plus prednisone or prednisolone regimen in delaying cancer progression and worsening of symptoms1

The ITC compared all published Phase 3 data of these treatments, leveraging longitudinal results, and findings reinforce the importance of consistent, sustained disease control in managing a chronic autoantibody disease like gMG IMAAVY (nipocalimab), an FcRn blocker, received U.S. FDA approval earlier this year for the broad population of individuals living with gMG, including anti-AChR and anti-MuSK antibody positive adults and paediatric gMG patients aged 12 and older

If approved, daratumumab will be the first authorised treatment option for patients with smouldering multiple myeloma at high-risk of developing multiple myeloma, offering the potential for disease interception1 Recommendation backed by results from the Phase 3 AQUILA study, which demonstrate that daratumumab has the potential to significantly delay the onset of myeloma and the need for treatment, as well as to extend overall survival2