Innovative Medicine

Marks first FDA submission for nipocalimab, an investigational treatment that binds with high affinity and specificity to block FcRn and reduce levels of autoantibodies Filing based on the Phase 3 Vivacity-MG3 program, the first-and-only study results in the class demonstrating sustained disease control over 24 weeks in antibody positive adult patients: anti-AChR+, anti-MuSK+, anti-LRP4+

Patients with EGFR ex19del or EGFR L858R mutations, the most common EGFR mutations in NSCLC, have until now faced a poor prognosis and limited treatment options after disease progression on an EGFR TKI1,2,3,4 Amivantamab in combination with chemotherapy is the first treatment regimen to show significant improvement in progression-free survival compared to chemotherapy alone in this patient population5

Four RYBREVANT® (amivantamab-vmjw) studies feature compelling new findings in lung and colorectal cancers New TAR-200 data reveal the potential of organ-sparing therapy for the treatment of bladder cancer

First pan FGFR kinase inhibitor to be approved in the European Economic Area, for adults with unresectable or metastatic urothelial carcinoma and susceptible FGFR3 alterations Approval based on THOR results, showing 36 percent reduction in risk of death with erdafitinib versus chemotherapy1

RYBREVANT® plus LAZCLUZE™ is the first and only chemotherapy-free regimen showing superior progression-free survival versus osimertinib Following Priority Review, approval is based on Phase 3 MARIPOSA results showing RYBREVANT® plus LAZCLUZE™ reduced the risk of disease progression or death by 30 percent versus osimertinib, with a nine-month-longer median duration of response

Nipocalimab delayed or prevented severe fetal anemia and 54 percent of study participants in the Phase 2 UNITY study achieved a live birth at or after 32 weeks without the need for intrauterine transfusion (IUT) The AZALEA Phase 3 clinical study is currently enrolling patients: Nipocalimab is the only therapy in clinical development for use in pregnancies at risk for severe hemolytic disease of the fetus and newborn (HDFN)

Patients with EGFR ex19del or EGFR L858R mutations, the most common EGFR mutations in NSCLC, currently face a poor prognosis and limited treatment options after disease progression on osimertinib1,2,3,4 In the MARIPOSA-2 study, amivantamab in combination with chemotherapy significantly reduced the risk of disease progression or death by 52 percent compared to chemotherapy alone, and is the first treatment regimen to show improvement in progression-free survival in this patient population5

Findings from first-ever quadruplet therapy study with subcutaneous DARZALEX FASPRO® showed 60 percent reduction in risk of disease progression or death New regimen solidifies DARZALEX FASPRO® as a foundational frontline therapy in multiple myeloma with potential to significantly delay disease progression

Phase 4 SPRAVATO® monotherapy data shows rapid improvement in depressive symptoms at ~24 hours, sustained through at least 4 weeks Monotherapy submission builds on more than a decade of research, 31 clinical trials and more than five years of real-world use that reinforce the safety and efficacy of SPRAVATO®