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Innovative Medicine
August 20, 2024
RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) approved in the U.S. as a first-line chemotherapy-free treatment for patients with EGFR-mutated advanced lung cancer
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
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Innovative Medicine
August 7, 2024
Groundbreaking nipocalimab study of pregnant individuals at high risk for early onset severe hemolytic disease of the fetus and newborn published in The New England Journal of Medicine
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)
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Innovative Medicine
July 31, 2024
CHMP recommends RYBREVANT®▼ (amivantamab) in combination with chemotherapy for the treatment of adult patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC) after failure of prior therapy
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
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Innovative Medicine
July 30, 2024
DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based quadruplet regimen approved in the U.S. for patients with newly diagnosed multiple myeloma who are transplant-eligible
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
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Innovative Medicine
July 22, 2024
Johnson & Johnson seeks U.S. FDA approval of SPRAVATO® (esketamine) as the first and only monotherapy for adults with treatment-resistant depression
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®
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Innovative Medicine
July 11, 2024
Johnson & Johnson strengthens pipeline to lead in atopic dermatitis with acquisition of Yellow Jersey Therapeutics
NM26 is a Phase 2-ready, first-in-class bispecific antibody targeting two clinically proven pathways in atopic dermatitis (AD) The Company is leveraging a multi-pathway approach to transform treatment in atopic dermatitis and other immune-mediated diseases
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