Press releases

New Drug Application supported by results from the Phase 2b SunRISe-1 study

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

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

Pending the European Commission final decision, regimen offers a new standard of care for eligible MCL patients1, 2 Positive opinion reinforces Phase 3 TRIANGLE study results by the European MCL Network, showing ibrutinib plus chemotherapy delivers significantly improved overall survival without the burden of transplant1,2

Results from the Phase 2 RedirecTT-1 study demonstrate deep responses with 78.9 percent overall response rate through dual targeting of GPRC5D and BCMA Data signal potential of novel, off-the-shelf approach in patients with extramedullary disease who face significant unmet needs

Phase 1b study suggests a promising safety profile and highlights the potential of a novel dual-targeting CD19/CD20 CAR T in patients with relapsed or refractory disease 75-80% complete response rate among evaluable patients at the recommended Phase 2 dose