EMEA Search Results

Oncology

RYBREVANT®▼ (amivantamab) in combination with chemotherapy is the first therapy approved by the European Commission for the first-line treatment of patients with advanced non-small cell lung cancer with activating EGFR exon 20 insertion mutations

Approval is supported by the Phase 3 PAPILLON study, which showed amivantamab plus chemotherapy significantly reduced the risk of disease progression or death by 60 percent compared to chemotherapy alone1

Immunology

Nipocalimab pivotal Phase 3 trial demonstrates sustained disease control in FcRn class for a broad population of myasthenia gravis patients

First FcRn blocker to demonstrate superiority in Myasthenia Gravis - Activities of Daily Living score (MGADL) a over placebo when added to standard of care over 24 weeks in antibody positive patients: antiAChR+, anti-MuSK+ and anti-LRP4+

Immunology

TREMFYA® (guselkumab) studies underscore its potential to be the first IL-23 inhibitor to offer both intravenous (IV) and subcutaneous (SC) induction for Crohn’s disease

In Phase 3 GRAVITI study guselkumab achieves all primary and secondary endpoints

Oncology

TALVEY®▼ (talquetamab) demonstrated highly durable, longer-term responses in patients with relapsed or refractory multiple myeloma

24-month overall survival rate of 67 percent achieved with talquetamab 0.8mg/kg biweekly dosing in the Phase 1/2 MonumenTAL-1 study1

Oncology

Findings from landmark RESONATE-2 study confirm sustained survival benefit of IMBRUVICA® (ibrutinib) for first-line chronic lymphocytic leukaemia treatment with up to 10 years follow-up

RESONATE-2 data presented at the 2024 European Hematology Association (EHA) Congress provide longestterm outcomes and safety data ever reported for a monotherapy BTK inhibitor, with a median progression-free survival of 8.9 years1 Additional findings from pooled analysis of three Phase 3 studies showed treatment with ibrutinib has the potential to achieve comparable overall survival to the general European population2RESONATE-2 data presented at the 2024 European Hematology Association (EHA) Congress provide longestterm outcomes and safety data ever reported for a monotherapy BTK inhibitor, with a median progression-free survival of 8.9 years1

Oncology

Updated Phase 2 CAPTIVATE study results demonstrate sustained clinical benefit of fixed-duration IMBRUVICA® (ibrutinib) plus venetoclax as first-line treatment for patients with chronic lymphocytic leukaemia, including those with high-risk disease

At 5 years, 67 percent of patients were progression-free, with overall survival at 96 percent for all treated patients1

Oncology

TECVAYLI®▼ (teclistamab) shows sustained deep and durable responses in patients with relapsed or refractory multiple myeloma

New MajesTEC-1 data show a median duration of response of 24 months, with responses deepening, including in patients who switched to biweekly dosing1 Separate analyses from the MajesTEC-1 and OPTec studies are the first to underscore the opportunity for outpatient administration of teclistamab2,3

Oncology

Late-breaking results from PALOMA-2 study of subcutaneous RYBREVANT®▼ (amivantamab) in combination with lazertinib show clinically meaningful antitumour response and improved safety profile in patients with EGFR-mutated non-small cell lung cancer

Significantly lower infusion-related reactions seen with subcutaneous amivantamab compared with intravenous administration in new Phase 2 data1

Oncology

CARVYKTI®▼ (ciltacabtagene autoleucel; cilta-cel) significantly improved progressionfree survival and deepened responses versus two standard therapies for patients with functional high-risk multiple myeloma

73 percent reduction in risk of disease progression or death seen with cilta-cel in the CARTITUDE-4 study in a subset of patients who had early relapse after initial multiple myeloma therapy1

Oncology

DARZALEX® (daratumumab)-based regimens significantly improved clinical outcomes in both transplant-eligible and -ineligible patients who are newly diagnosed with multiple myeloma

88 percent of transplant-eligible patients achieved a complete response or better, and 47 percent of patients sustained MRD-negativity for longer than one year with daratumumab subcutaneous formulation-based regimens in the Phase 3 PERSEUS study1 7.5 years median overall survival achieved with daratumumab-based regimen in Phase 3 MAIA final survival analysis is the longest reported in patients ineligible for transplant2

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