Landmark Phase 3 MARIPOSA Study Shows RYBREVANT®▼(amivantamab) Plus Lazertinib Resulted in 30 Percent Reduction in Risk of Disease Progression or Death Compared to Osimertinib in Patients with EGFR-Mutated Non-Small Cell Lung Cancer
October 23, 2023 10:59 ET
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Janssen Pharmaceutica NV
Early data show an overall survival trend favoring the combination of amivantamab and lazertinib compared to osimertinib; consistent results seen in patients with and without brain metastases1 ...
TAR-200 Intravesical Delivery System Results Show 77 Percent Complete Response Rate in Patients with Bacillus-Calmette Guérin Unresponsive, High-Risk Non-Muscle-Invasive Bladder Cancer
October 22, 2023 05:39 ET
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Janssen Pharmaceutica NV
Phase 2b SunRISe-1 study results showed sustained, durable complete responses beyond one year with intravesical gemcitabine delivery system.1 BEERSE, BELGIUM, Oct. 22, 2023 (GLOBE NEWSWIRE) -- The...
First Results with Erdafitinib-Releasing Intravesical Delivery System (TAR-210) Show Early Evidence of Positive Clinical Activity in Patients with Non-Muscle-Invasive Bladder Cancer with Select Fibroblast Growth Factor Receptor Alterations
October 22, 2023 04:35 ET
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Janssen Pharmaceutica NV
Investigational TAR-210 first-in-human results highlight the potential for local sustained release of erdafitinib with a novel intravesical delivery system.1 Phase 1 results show a manageable safety...
Final Multivariate Analysis from the Phase 3 MAGNITUDE Study Shows Trend Towards Improvement in Overall Survival in Patients with Metastatic Castration-Resistant Prostate Cancer with BRCA Alterations Treated with Niraparib and Abiraterone Acetate Plus Prednisone
October 22, 2023 03:50 ET
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Janssen Pharmaceutica NV
Niraparib and abiraterone acetate plus prednisone combination therapy also showed clinically relevant improvement versus standard of care in time to symptomatic progression and time to cytotoxic...
New Data from Phase 3 PAPILLON Study Show RYBREVANT®▼ (amivantamab) Plus Chemotherapy Resulted in 60 Percent Reduction in Risk of Disease Progression or Death in Patients with Previously Untreated EGFR Exon 20 Insertion Mutation-Positive Non-Small Cell Lung Cancer
October 21, 2023 10:48 ET
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Janssen Pharmaceutica NV
Data show the potential impact of amivantamab and chemotherapy combination as first-line treatment for patients with advanced non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations1 ...
Results from Phase 2 THOR-2 Study Showed Improved Rates of Recurrence-Free Survival in Patients with High-Risk Non-Muscle-Invasive Bladder Cancer with Select Fibroblast Growth Factor Receptor Alterations Treated with Erdafitinib Versus Chemotherapy
October 21, 2023 03:47 ET
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Janssen Pharmaceutica NV
Data from Cohort 1 of the Phase 2 THOR-2 study showed oral erdafitinib reduced the risk of disease recurrence or death compared with intravesical standard-of-care chemotherapy1 ...
Janssen reicht bei der Europäischen Arzneimittel-Agentur einen Antrag für RYBREVANT®▼ (Amivantamab) in Kombination mit Chemotherapie zur Erstbehandlung von erwachsenen Patienten mit fortgeschrittenem nicht-kleinzelligem Lungenkrebs mit aktivierenden EGFR-Exon-20-Insertionsmutationen ein
October 11, 2023 13:15 ET
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Janssen EMEA
Der Antrag auf Indikationserweiterung des Typs II wird durch Daten aus PAPILLON gestützt, der ersten randomisierten Phase-III-Studie, die bei Patienten mit NSCLC mit EGFR-Exon-20-Insertionsmutationen...
Janssen soumet une demande d’autorisation de mise sur le marché à l’Agence européenne des médicaments pour RYBREVANT®▼ (amivantamab) en association à la chimiothérapie dans le traitement en première intention des patients adultes atteints de carcinome bronchique non à petites cellules (CBNPC) au stade avancé avec des mutations d’insertion de l’exon 20 du récepteur du facteur de croissance épidermique (R-EGF)
October 11, 2023 12:52 ET
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Janssen EMEA
La demande de prolongation de type II de l’indication du médicament est étayée par les données provenant de PAPILLON, la première étude randomisée de phase III à entraîner des résultats chez les...
Janssen presenta a la Agencia Europea del Medicamento la solicitud de RYBREVANT®▼ (amivantamab) en combinación con quimioterapia para el tratamiento de primera línea de pacientes adultos con cáncer de pulmón no microcítico avanzado con mutaciones activadoras de inserción en el exón 20 del receptor EGFR
October 11, 2023 12:33 ET
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Janssen EMEA
La solicitud de extensión de la indicación de tipo II está respaldada por los datos de PAPILLON, el primer estudio aleatorizado de fase 3 en pacientes con CPNM con mutaciones de inserción del exón 20...
New Safety Data Suggests SPRAVATO®▼ (Esketamine Nasal Spray) is More Tolerable and Effective Compared to Quetiapine Extended-Release (XR) in Adults with Treatment-resistant Major Depressive Disorder
October 08, 2023 09:00 ET
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Janssen Pharmaceutica NV
Beerse, Belgium, Oct. 08, 2023 (GLOBE NEWSWIRE) -- The new safety data is from the ESCAPE-TRD Phase 3b study1Additional findings from this study showed esketamine NS demonstrated a significant...