Innovative Medicine
CARVYKTI® (ciltacabtagene autoleucel) achieved statistically significant and clinically meaningful improvement
CARVYKTI ® is the first and only BCMA-targeted CAR-T cell therapy approved by the U.S. FDA for the treatment of patients with multiple myeloma who have had at least one prior line of therapy
Subcutaneous amivantamab Biologics License Application submitted to U.S. FDA for patients with EGFR-mutated non-small cell lung cancer
Application based on Phase 3 PALOMA-3 results showing five-fold reduction in infusion-related reactions with five-minute administration of subcutaneous amivantamab Longer overall survival, progression-free survival and duration of response also observed with subcutaneous amivantamab
TALVEY® (talquetamab-tgvs) demonstrates highly durable, longer-term responses in patients with relapsed or refractory multiple myeloma
24-month overall survival rate of 67 percent achieved with TALVEY® 0.8 mg/kg biweekly dosing in the Phase 1/2 MonumenTAL-1 study
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 longest-term 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 population2
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
CARVYKTI® (ciltacabtagene autoleucel) significantly improved progression-free 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 CARVYKTI® in the CARTITUDE-4 study in a subset of patients who had early relapse after initial multiple myeloma therapy1
DARZALEX® (daratumumab)-based regimens significantly improve 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 DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based induction, consolidation and maintenance regimens in the Phase 3 PERSEUS study 7.5 years median overall survival achieved with DARZALEX®-based regimen in Phase 3 MAIA final analysis is the longest reported in patients ineligible for transplant
Late-breaking results from PALOMA-2 study of subcutaneous amivantamab in combination with lazertinib show clinically meaningful antitumor 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 data
TECVAYLI® (teclistamab-cqyv) 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 TECVAYLI®