Innovative Medicine
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Janssen Submits Supplemental Biologics License Application to the U.S. Food and Drug Administration Seeking Approval of RYBREVANT® (amivantamab-vmjw) in Combination with Chemotherapy for the First-line Treatment of Patients with Locally Advanced or Metastatic EGFR Exon 20 Insertion Mutation-Positive Non-Small Cell Lung Cancer
Application is supported by data from PAPILLON, the first randomized Phase 3 study to show clinically meaningful results in patients with NSCLC with EGFR exon 20 insertion mutations -
European Commission Approves TALVEY®▼ (talquetamab), Janssen’s Novel Bispecific Therapy for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma
Talquetamab, the first bispecific antibody targeting GPRC5D, showed an overall response rate of more than 70 percent with durable responses, including responses achieved by over 60 percent of patients with prior T-cell redirection therapy.1,2 -
European Commission Approves Reduced Dosing Frequency for Janssen’s Bispecific Antibody TECVAYLI®▼ (teclistamab)
Teclistamab, the first BCMA-targeting bispecific antibody to receive approval in Europe, maintained deep and durable responses, with reduced onset of Grade 3 or higher infections, in eligible patients with relapsed and refractory multiple myeloma (RRMM) switching from weekly to reduced, biweekly dosing schedule.1,2 -
U.S. FDA Approves AKEEGA™ (Niraparib and Abiraterone Acetate), the First-And-Only Dual Action Tablet for the Treatment of Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer
Approval is based on the Phase 3 MAGNITUDE study, a prospectively designed precision medicine study including the largest population of BRCA-positive patients in combination trials to date with metastatic castration-resistant prostate cancer (mCRPC) AKEEGA™ plus prednisone significantly improved radiographic progression-free survival compared to abiraterone acetate plus prednisone (AAP) in patients with BRCA-positive mCRPC -
U.S. FDA Approves TALVEY™ (talquetamab-tgvs), a First-in-Class Bispecific Therapy for the Treatment of Patients with Heavily Pretreated Multiple Myeloma
Bispecific antibody targeting GPRC5D receptor showed an overall response rate of more than 70 percent with durable responses, including in patients previously treated with a bispecific antibody or CAR-T cell therapy -
Janssen Submits Supplemental New Drug Application to U.S. FDA Seeking Expanded Pediatric Indication for HIV-1 Therapy EDURANT®
Parallel application also submitted to European Medicines Agency If approved, EDURANT® (rilpivirine) in combination with other antiretroviral therapies would offer a new HIV-1 treatment option for younger children -
Johnson & Johnson Launches Exchange Offer for Separation of Kenvue Inc.
Separation enhances Company focus on Pharmaceutical and MedTech Research & Development to deliver innovative and differentiated health outcomes Johnson & Johnson shareholders can exchange all, some or none of their shares of Johnson & Johnson common stock for shares of Kenvue Provides Johnson & Johnson shareholders with option for a tax-free exchange for U.S. Federal income tax purposes -
Janssen Receives Positive CHMP Opinions for Novel Bispecific Antibodies TALVEY®▼ (talquetamab) and TECVAYLI®▼ (teclistamab) for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma
Talquetamab is the first therapy targeting GPRC5D to receive a positive CHMP Opinion Teclistamab, the first BCMA-targeting bispecific antibody to be approved in Europe, receives positive CHMP Opinion for reduced, biweekly dosing schedule -
Treatment with RYBREVANT® (amivantamab-vmjw) Plus Chemotherapy Resulted in Statistically Significant and Clinically Meaningful Improvement in Progression-Free Survival in Patients with Newly Diagnosed EGFR Exon 20 Insertion Mutation-Positive Non-Small Cell Lung Cancer
First Phase 3 study to demonstrate clinically meaningful results versus standard of care in a newly diagnosed exon 20 population, a patient population with high unmet medical need