Innovative Medicine
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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 -
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 -
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® -
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 -
Johnson & Johnson Receives Approval from U.S. FDA and European Commission for SIRTURO® (bedaquiline)
Approvals supported by Phase 3 STREAM Stage 2 study results confirming favorable treatment outcomes compared to injectable-containing regimens Approvals of SIRTURO® follow accelerated approval by U.S. FDA in December 2012 and conditional approval by the EMA in March 2014 -
CARVYKTI® (ciltacabtagene autoleucel) achieved statistically significant and clinically meaningful improvement in overall survival in landmark CARTITUDE-4 study
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 -
Johnson & Johnson completes acquisition of Proteologix, Inc.
Acquisition includes two pre-clinical bispecific antibodies targeting proven disease pathways, offering the potential to transform the treatment paradigm for patients living with atopic dermatitis and other immune-mediated diseases -
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