Oncology news archive
Johnson & Johnson highlights its preeminent leadership in hematology through differentiated blood cancer portfolio and pipeline with new clinical and real-world data at ASH
Data highlights strength of multi-target, multi-platform multiple myeloma portfolio and continued innovation in B-cell malignancies to transform patient outcomes
Landmark Phase 3 MARIPOSA Study Shows RYBREVANT® (amivantamab-vmjw) 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
Early data show an overall survival trend favoring the combination of RYBREVANT® and lazertinib compared to osimertinib; consistent results seen in patients with and without brain metastases Late-breaking results from the MARIPOSA study featured in a Presidential Symposium at 2023 ESMO Congress
Phase 3 MARIPOSA-2 Study Shows RYBREVANT® (amivantamab-vmjw) Plus Chemotherapy Given with or without Lazertinib Reduced Risk of Disease Progression or Death by 56 and 52 Percent Respectively in Patients with EGFR-Mutated Non-Small Cell Lung Cancer who Progressed on or after Osimertinib
These RYBREVANT® regimens are the first to show improvement in progression-free survival compared to chemotherapy in patients with EGFR-mutated advanced non-small cell lung cancer (NSCLC) following prior osimertinib treatment Late-breaking results from MARIPOSA-2 study presented in a Presidential Symposium at 2023 ESMO Congress and simultaneously published in Annals of Oncology
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
Investigational TAR-210 first-in-human results highlight the potential for local sustained release of erdafitinib with a novel intravesical delivery system Phase 1 results show a manageable safety profile with limited systemic toxicity, and early complete responses in patients with high-risk and intermediate-risk NMIBC
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
Phase 2b SunRISe-1 study results showed sustained, durable complete responses beyond one year with intravesical gemcitabine delivery system
Final Multivariate Analysis from the Phase 3 MAGNITUDE Study Shows Trend Toward Improvement in Overall Survival in Patients with Metastatic Castration-Resistant Prostate Cancer with BRCA Alterations Treated with Niraparib and Abiraterone Acetate Plus Prednisone
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 chemotherapy
New Data from Phase 3 PAPILLON Study Show RYBREVANT® (amivantamab-vmjw) 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
Data show the potential impact of RYBREVANT® and chemotherapy combination as first-line treatment for patients with advanced non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations Late-breaking data presented in a Presidential Symposium at 2023 ESMO Congress and simultaneously published in The New England Journal of Medicine
Results from Phase 2 THOR-2 Study Show 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 BALVERSA® (erdafitinib) Versus Chemotherapy
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 chemotherapy
Janssen Aims to Define New Standards of Care in the Treatment of Solid Tumor Cancers with Transformative Data Planned for Presentation at ESMO
Three Phase 3 RYBREVANT® (amivantamab-vmjw) studies (MARIPOSA, MARIPOSA-2 and PAPILLON) in EGFR-mutated lung cancer achieved statistically significant and clinically meaningful progression-free survival endpoints and will be presented in Presidential Symposium sessions New results for investigational TAR-200 and TAR-210 novel intravesical delivery system highlight potential for transformational outcomes in the treatment of bladder cancer
Landmark Phase 3 MARIPOSA Study Meets Primary Endpoint Resulting in Statistically Significant and Clinically Meaningful Improvement in Progression-Free Survival for RYBREVANT® (amivantamab-vmjw) plus Lazertinib Versus Osimertinib in Patients with EGFR-Mutated Non-Small Cell Lung Cancer
Planned interim overall survival analysis showed a trend favoring the combination of RYBREVANT® and lazertinib compared to osimertinib* First pivotal study to show a clinically meaningful benefit in a chemotherapy-free regimen versus osimertinib
Janssen Demonstrates Commitment to Transform the Treatment of Multiple Myeloma through Innovative Science and Industry-Leading Portfolio with Largest-Ever Presence at 20th International Myeloma Society Annual Meeting
Presentations to highlight latest data across biologic, bispecific and CAR-T therapies with added insights from Global Multiple Myeloma Call-to-Action
Treatment with RYBREVANT® (amivantamab-vmjw) and Lazertinib Plus Chemotherapy Showed Durable Progression-Free Survival in Patients with Previously Treated EGFR-Mutated Advanced Non-Small Cell Lung Cancer
Data presented at WCLC showed combining RYBREVANT ®, lazertinib and chemotherapy may address the diverse resistance that emerges after disease progression on osimertinib
Janssen Submits Marketing Authorisation Application to the European Medicines Agency Seeking Approval of Erdafitinib for the Treatment of Patients with Locally Advanced or Metastatic Urothelial Cancer with Susceptible FGFR Alterations
Pending approval, erdafitinib, an investigational, once-daily oral pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor,1will become the first therapy targeting FGFR alterations2 in patients with metastatic urothelial carcinoma, one of Europe’s most common cancers3,4 The submission is based on results from the Phase 3 THOR study, which were featured in a Late-Breaking Presentation Session at the 2023 ASCO Annual Meeting in June5
Phase 3 MARIPOSA-2 Study Meets Dual Primary Endpoint Resulting in Statistically Significant and Clinically Meaningful Improvement in Progression-Free Survival for RYBREVANT® (amivantamab-vmjw) Plus Chemotherapy With and Without Lazertinib versus Chemotherapy Alone in Patients with EGFR-Mutated Non-Small Cell Lung Cancer after Disease Progression on Osimertinib
MARIPOSA-2 is the first Phase 3 study to show statistically significant and clinically meaningful improvement in progression-free survival (PFS) in the post-osimertinib setting MARIPOSA-2 is the second RYBREVANT® Phase 3 study to show the potential to improve outcomes in patients with EGFR-mutated non-small cell lung cancer (NSCLC)
Janssen Submits Supplemental New Drug Application to the U.S. Food and Drug Administration Seeking Full Approval of BALVERSA® (erdafitinib) for the Treatment of Patients with Locally Advanced or Metastatic Urothelial Carcinoma and Selected Fibroblast Growth Factor Receptor Gene Alterations
Submission Based on Confirmatory Data from Cohort 1 of the Phase 3 THOR Study, Which Showed a 36 Percent Reduction in the Risk of Death in Patients Treated with BALVERSA® Versus Chemotherapy
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 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 Presents Longer-Term Data for TECVAYLI® (teclistamab-cqyv) Showing a Duration of Response of 22 Months in Patients with Relapsed or Refractory Multiple Myeloma
More than 60 percent of patients achieved an overall response and 45.5 percent of patients achieved a complete response or better by nearly five months Additional data highlights strong efficacy with biweekly TECVAYLI® dosing and show strategies for improving cytokine release syndrome with prophylactic tocilizumab
Janssen Submits Supplemental Biologics License Application to U.S. FDA Seeking Approval of CARVYKTI® for the Earlier Treatment of Patients with Relapsed or Refractory Multiple Myeloma
Application is supported by data from the Phase 3 CARTITUDE-4 study, which showed significant improvement in primary endpoint of progression-free survival (PFS) CARTITUDE-4 is the first randomized Phase 3 study investigating the efficacy of a cell therapy as early as after first relapse in multiple myeloma
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
Janssen Enters Worldwide Collaboration and License Agreement with Cellular Biomedicine Group to Develop Next Generation CAR-T Therapies
Investigational CD20-targeted CAR-Ts Enhance Janssen’s B-cell Malignancy Portfolio Agreement Deepens Janssen’s Leadership in Oncology and Hematology, and Accelerates Commitment to Delivering Transformational Cell Therapies
Janssen Reports First Results from Phase 2 SunRISe-1 Study of TAR-200 and Anti- PD-1 Antibody Cetrelimab in Patients with Bacillus Calmette-Guérin-Unresponsive Non-Muscle-Invasive Bladder Cancer
Study results of novel drug-eluting technology highlight potential durability of TAR-200 in patient population with high unmet need
ERLEADA® (apalutamide), First-and-Only Next-Generation Androgen Receptor Inhibitor with Once-Daily, Single-Tablet Option, Now Available in the U.S.
Addition of 240mg strength allows prescribers flexibility to prescribe one 240mg tablet or four 60mg tablets once-daily based on patient needs
Janssen Marks First Approval Worldwide for AKEEGA® (Niraparib and Abiraterone Acetate Dual Action Tablet) with EC Authorization for the Treatment of Patients with Metastatic Castration Resistant Prostate Cancer with BRCA1/2 Mutations
Approval for AKEEGA® is based on results from the Phase 3 MAGNITUDE study, a prospectively designed precision medicine study that includes the largest cohort to date of BRCA1/2-positive patients with untreated metastatic castration-resistant prostate cancer (mCRPC).1,2 Niraparib in combination with abiraterone acetate (AA), plus prednisone or prednisolone, significantly improved radiographic progression-free survival (rPFS) compared to standard of care in untreated mCRPC patients with BRCA1/2 mutations.3
Janssen Submits New Drug Application to the U.S. Food and Drug Administration Seeking Approval of Niraparib and Abiraterone Acetate Dual-Action Tablet, Plus Prednisone, as a First-Line Targeted Treatment for Patients with Metastatic Castration-Resistant Prostate Cancer with BRCA Gene Mutations
Niraparib and Abiraterone Acetate Plus Prednisone Has Potential to Address Unmet Need for Patients with BRCA-Positive mCRPC
Janssen Receives Positive CHMP Opinion for AKEEGA® (Niraparib and Abiraterone Acetate Dual Action Tablet) Plus Prednisone or Prednisolone for the Treatment of Adult Patients with BRCA1/2 Gene-Mutated Metastatic Castration Resistant Prostate Cancer
If approved, niraparib in combination with abiraterone acetate (AA), will be the first dual action tablet (DAT) available in the European Union for first-line treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) with BRCA1/2 mutations, when given with prednisone (P) or prednisolone.[i] The positive CHMP opinion is based on results from the Phase 3 MAGNITUDE study where the addition of niraparib to AA plus P significantly improved radiographic progression-free survival (rPFS) compared to standard of care in untreated mCRPC patients with BRCA1/2 mutations.[ii]
Janssen Presents Updated Data Demonstrating Improved Outcomes from the Use of Niraparib in Combination with Abiraterone Acetate Plus Prednisone as a First-Line Therapy in Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer
Results from the Phase 3 MAGNITUDE study second interim analysis to be featured in an oral presentation at ASCO GU
Janssen Data at ASCO GU Support Ambition to Transform Treatment of Prostate and Bladder Cancer Through Precision Medicine and Early Intervention
Updated data from the Phase 3 MAGNITUDE study of niraparib in combination with abiraterone acetate plus prednisone in patients with metastatic castration-resistant prostate cancer will be featured
Janssen Announces Unblinding of Phase 3 CARTITUDE-4 Study of CARVYKTI® (cilta-cel) as Primary Endpoint Met in Treatment of Patients with Relapsed and Refractory Multiple Myeloma
Study unblinded following recommendation of Independent Data Monitoring Committee
Real-World Study Shows Patients Treated with IMBRUVICA® (ibrutinib) Were Less Likely to Initiate a Next-Line Treatment than Patients on Acalabrutinib in First-line Chronic Lymphocytic Leukemia
More than two years of electronic medical records indicate patients were 89 percent more likely to start a next-line treatment when on acalabrutinib versus IMBRUVICA®
Janssen Presents Efficacy and Subgroup Analyses from MAIA Study Showing Long-Term Results of DARZALEX® (daratumumab)-based Regimen in Newly Diagnosed, Transplant-Ineligible Multiple Myeloma
Updated analyses report on progression-free survival, minimal residual disease negativity, overall response and overall survival across patient types, regardless of age or cytogenetic risk Five-year follow-up highlights health-related quality of life data in a subgroup of frail patients
Janssen Presents First Data from MajesTEC-2 Trial of TECVAYLI™ (teclistamab-cqyv) in Combination with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) and Lenalidomide in Relapsed or Refractory Multiple Myeloma
Initial Phase 1b study results show clinical activity with immune-based triplet therapy regimen
Janssen Presents New Data for Talquetamab, a First-in-Class GPRC5DxCD3 Bispecific Antibody, Suggesting Durable Responses in Patients with Heavily Pretreated Multiple Myeloma
Results from the pivotal MonumenTAL-1 study, including first results from the Phase 2 portion, featured at the 2022 ASH Annual Meeting
New Results from the Phase 3 GLOW Study of Fixed-Duration Treatment with IMBRUVICA® (ibrutinib) Plus Venetoclax Demonstrate Robust Efficacy and Sustained Response in Older, Unfit Patients with Previously Untreated Chronic Lymphocytic Leukemia
With nearly four years of study follow-up, all-oral, fixed duration IMBRUVICA® + venetoclax reduced the risk of progression or death by 79 percent and demonstrated overall survival (OS) advantage versus chemoimmunotherapy
Janssen to Highlight Latest Scientific Advances in Hematologic Diseases at ASH 2022 with Clinical and Real-World Data Across Innovative Pipeline and Distinguished Portfolio
More than 50 presentations across hematologic malignancies and diseases demonstrate Janssen’s commitment to innovation and transforming the treatment of blood cancers across lines of therapy and patient types
U.S. FDA Approves TECVAYLI™ (teclistamab-cqyv), the First Bispecific T-cell Engager Antibody for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
TECVAYLI™, an off-the-shelf, subcutaneous therapy, is an important new medicine for patients with incurable blood cancer who face limited treatment options
Final Analysis of Phase 2 GRIFFIN Study Presented for DARZALEX® (daratumumab)-based Investigational Quadruplet Regimen in Patients with Newly Diagnosed, Transplant-Eligible Multiple Myeloma
Data featured in plenary session at the 19th International Myeloma Society Annual Meeting
U.S. FDA Approves IMBRUVICA® (ibrutinib) as First and Only BTKi Treatment for Pediatric Patients with Chronic Graft-Versus-Host Disease
IMBRUVICA® is now the only BTKi with 12 FDA approvals across seven indications, including five hematologic cancers and cGVHD
Janssen Marks First Approval Worldwide for TECVAYLI® (teclistamab) with EC Authorisation of First-in-Class Bispecific Antibody for the Treatment of Patients with Multiple Myeloma
Teclistamab, an off-the-shelf (ready to use) subcutaneously administered therapy, induced deep and rapid responses in triple-class exposed patients with relapsed and refractory multiple myeloma[1]
Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for Talquetamab for the Treatment of Relapsed or Refractory Multiple Myeloma
Novel GPRC5DxCD3 Bispecific Antibody Receives Breakthrough Therapy Designation Based Upon Results from the Phase 1/2 MonumenTAL-1 Study
Janssen Presents Updated Data at EHA for Teclistamab in Patients with Relapsed or Refractory Multiple Myeloma
Data show a combination of teclistamab (BCMAxCD3 bispecific antibody) plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) improved clinical efficacy in heavily pretreated patients with relapsed or refractory multiple myeloma
New IMBRUVICA® (ibrutinib) Data in Fixed-Duration Combination Regimen Presented at EHA 2022 Shows Deep, Durable Response at Three Years in Untreated Chronic Lymphocytic Leukemia
The all-oral, once-daily combination regimen also demonstrates the potential of immune restoration in this patient population
Janssen Presents Updated Results Evaluating First-in-Class GPRC5D Bispecific Antibody Talquetamab in Heavily Pretreated Patients with Multiple Myeloma
Updated results for talquetamab monotherapy and in combination with daratumumab highlighted in oral presentations at the 2022 EHA Annual Congress
Janssen Presents Initial Results from the Phase 2 RAGNAR Study of BALVERSA® (erdafitinib) in Patients with Advanced Solid Tumors with FGFR Alterations
Data from RAGNAR, the largest tumor-agnostic study reported for a targeted therapy and the first to evaluate FGFR-driven malignancies, featured in oral presentation at the 2022 ASCO Annual Meeting
Updated Data for Janssen’s Bispecific Teclistamab Suggest Continued Deep and Durable Responses in the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
New teclistamab data presented at the 2022 ASCO Annual Meeting report longer follow-up from Phase 1/2 MajesTEC-1 study evaluating the BCMAxCD3 bispecific antibody, including progression-free survival and subgroup analyses Data from MajesTEC-1 study published in The New England Journal of Medicine
Longer-term Data from CARTITUDE-1 Study Demonstrate Continued Deep and Durable Responses to CARVYKTI™ (ciltacabtagene autoleucel) in Heavily Pretreated Patients with Relapsed or Refractory Multiple Myeloma
At nearly 28 months of median follow-up, median progression-free survival and overall survival were not yet reached Data presented at the 2022 ASCO Annual Meeting and published in the Journal of Clinical Oncology
Phase 3 SHINE Results Show IMBRUVICA® (ibrutinib)-Based Combination Regimen Significantly Reduced the Risk of Disease Progression or Death in Older Patients with Newly Diagnosed Mantle Cell Lymphoma
Primary results from the first frontline Phase 3 study of a Bruton’s tyrosine kinase inhibitor in MCL to be presented as late-breaking data at the 2022 ASCO Annual Meeting and also published in The New England Journal of Medicine
Janssen to Highlight Science, Innovation and Advances in Robust Oncology Portfolio and Pipeline Through More Than 60 Data Presentations at ASCO and EHA
Studies spanning industry-leading hematologic malignancies portfolio and pipeline with new research in solid tumor therapies to highlight precision medicine and targeted therapy strategies
European Commission Grants Conditional Approval of CARVYKTI® (Ciltacabtagene Autoleucel), Janssen’s First Cell Therapy, for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma
In the pivotal clinical study CARTITUDE-1, 98 percent of patients with relapsed or refractory multiple myeloma responded to a one-time treatment with ciltacabtagene autoleucel and 80 percent of patients who responded experienced a stringent complete response [1]
MPAACT Consortium Unites Industry and Academia to Establish Measurable Residual Disease as a Surrogate Endpoint in Acute Myeloid Leukemia Drug Development
Validated Measurable Residual Disease Assays are Critical for the Rapid Development of Future Novel Therapeutics for Patients with Acute Myeloid Leukemia
Janssen Seeks Approval of a New Indication for IMBRUVICA® (ibrutinib) for Use in Patients with Untreated Mantle Cell Lymphoma
Application based on Phase 3 SHINE study results, which investigated the safety and efficacy of all-oral ibrutinib in combination with bendamustine and rituximab in adult patients with previously untreated mantle cell lymphoma[1]
Janssen Presents New Data Demonstrating the Combination of Niraparib and Abiraterone Acetate Plus Prednisone Significantly Improved Radiographic Progression-Free Survival as a First-Line Therapy in Patients with HRR Gene-Mutated Metastatic Castration-Resistant Prostate Cancer
Initial results from Phase 3 MAGNITUDE study, to be featured in a late-breaking oral presentation at ASCO GU, highlight subset of patients with mCRPC most likely to benefit from treatment
New ERLEADA® (apalutamide) Analysis Demonstrates Rapid, Deep Prostate-Specific Antigen (PSA) Response in Patients with Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
Real-world evidence study demonstrates majority of patients with mCSPC achieved over 90 percent decline in PSA by six months after initiation of ERLEADA® Rapid and deep PSA decline is associated with improved health-related quality of life in advanced prostate cancer as shown by separate post-hoc analysis of patient-reported outcomes from Phase 3 SPARTAN and TITAN studies
Janssen Data at ASCO GU Demonstrate Longstanding Leadership in Prostate Cancer and Commitment to Advancing Potential New Therapeutic Options for Genitourinary Cancers
Initial results from Phase 3 MAGNITUDE study of niraparib in combination with abiraterone acetate plus prednisone as a first-line therapy in patients with metastatic castration-resistant prostate cancer featured as an oral presentation New data for ERLEADA® (apalutamide) build on more than a decade of experience in prostate cancer; updated clinical trial information for novel drug delivery system TAR-200 plus cetrelimab in early-stage bladder cancer to be presented
New Data from MajesTEC-1 Study Show Continued Deep and Durable Responses of Teclistamab (BCMAxCD3 Bispecific Antibody) in Treatment of Heavily Pretreated Patients with Multiple Myeloma
Phase 1b results of teclistamab in combination with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) also presented at ASH 2021 Annual Meeting
New Data from CARTITUDE-1 Study Show Continued Deep and Durable Responses of Ciltacabtagene Autoleucel (cilta-cel) in Treatment of Heavily Pretreated Patients with Multiple Myeloma
Data presented at ASH 2021 show 83 percent of patients achieved a stringent complete response at median follow-up of 22-months 92 percent of evaluable patients achieved minimal residual disease negativity, with progression-free survival and overall survival sustained in those patients for ≥6 and ≥12 months
Janssen Presents Updated Results Evaluating First-in-Class Talquetamab (GPRC5DxCD3 Bispecific Antibody) in Heavily Pretreated Patients with Multiple Myeloma
Updated results of weekly and biweekly dosing of talquetamab monotherapy and initial results in combination with daratumumab presented in oral presentations at the ASH 2021 Annual Meeting
New Clinical and Real-World Data Support Use of DARZALEX® (daratumumab) in Patients with Newly Diagnosed Multiple Myeloma
Investigational DARZALEX® quadruple combination regimen shows responses in newly diagnosed, transplant-eligible patients in randomized Phase 2 GRIFFIN study Real-world evidence analysis examines the impact of frontline versus second-line treatment with DARZALEX®-based combinations in transplant-ineligible patients
New Data from Phase 3 GLOW Study Show Fixed-Duration Treatment with IMBRUVICA® (ibrutinib) Plus Venetoclax Demonstrated Deeper and Sustained Undetectable Minimal Residual Disease Outcomes in First-Line Chronic Lymphocytic Leukemia
Updated results from the MRD cohort of the Phase 2 CAPTIVATE study also highlight potential for treatment-free remissions with IMBRUVICA® plus venetoclax in an oral presentation at ASH 2021
Janssen Seeks Approval of IMBRUVICA®(ibrutinib) in a Fixed-Duration Regimen for Patients with Untreated Chronic Lymphocytic Leukaemia (CLL)
Application based on Phase 3 GLOW and Phase 2 CAPTIVATE study results, which investigated the safety and efficacy of an all-oral fixed-duration ibrutinib plus venetoclax combination regimen in adult patients with previously untreated CLL (1) (2)
Janssen to Present the Strength and Promise of its Hematologic Malignancies Portfolio and Pipeline at ASH 2021
More than 80 abstracts will be presented, including data supporting Cilta-Cel, Teclistamab, Talquetamab, DARZALEX® (daratumumab) and IMBRUVICA® (ibrutinib) Additional data for XARELTO® (rivaroxaban), Nipocalimab and DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) to highlight Janssen’s research in other hematologic diseases
New Data on RYBREVANT® (amivantamab-vmjw) in Combination with Lazertinib Show Early Activity in Patients with Non-Small Cell Lung Cancer Whose Disease Has Progressed After Both Osimertinib and Platinum-Based Chemotherapy
CHRYSALIS-2 findings presented at ESMO Annual Congress 2021 suggest that RYBREVANT® and lazertinib combination has encouraging anti-tumor activity in this population that has exhausted standard-of-care treatments
RYBREVANT® (amivantamab-vmjw) Provides Higher Activity and Longer Duration of Response When Used in Combination with Lazertinib in Patients with Advanced EGFR-Mutant Non-Small Cell Lung Cancer Who Have Failed Osimertinib
New analysis from CHRYSALIS study presented at the ESMO Annual Congress 2021 supports simultaneously targeting the extracellular and catalytic domains of EGFR
Janssen Presents Results from Phase 1b/2 NORSE Study in Patients with Metastatic or Locally Advanced Urothelial Carcinoma Treated with BALVERSA® (erdafitinib) in Combination with Cetrelimab, a PD-1 Inhibitor
Oral presentation at ESMO Annual Congress 2021 – featured in a late-breaking abstract – reports efficacy and safety of BALVERSA® in combination with a PD-1 inhibitor in bladder cancer
ERLEADA® (apalutamide) Oral Presentations Demonstrate Importance of Prostate Specific Antigen (PSA) as Key Efficacy Indicator and Show Strong Patient Adherence Rates
Post-hoc analysis shows that ERLEADA® provides rapid, deep and durable PSA declines in advanced prostate cancer, with depth and speed of response correlating to improved overall survival Real-world data demonstrate that, across racial groups, patients prescribed ERLEADA® for non-metastatic castration-resistant prostate cancer stay on therapy
Striving to Deliver Better Outcomes: Janssen to Showcase Commitment to Advancing Science for Genitourinary Cancers at AUA 2021
Compelled to advance innovation for patients and the urology community, oral presentations highlight real-world effectiveness of and patient adherence to ERLEADA® (apalutamide), plus PSA response from Phase 3 TITAN and SPARTAN studies in patients with advanced prostate cancer
Janssen Presents Phase 1 Results for RYBREVANTTM (amivantamab-vmjw) in the Treatment of Patients with Advanced Non-Small Cell Lung Cancer with MET Exon 14 Skipping Mutations
Oral presentation at the International Association for the Study of Lung Cancer’s (IASLC) 2021 World Conference on Lung Cancer (WCLC) shows evidence that the bispecific mechanism of action for RYBREVANTTM can provide anti-tumor activity against either EGFR-mutated or MET-mutated non-small cell lung cancer
Janssen Demonstrates Commitment to Advancing Science and Innovation in the Treatment of Solid Tumors at ESMO Annual Congress
Data for approved and investigational treatments to be presented in bladder cancer, lung cancer and prostate cancer Investigational RYBREVANT® (amivantamab-vmjw) and lazertinib combination therapy in epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) to be featured in oral presentations
New Phase 3 Study Results Show IMBRUVICA® (ibrutinib)-Based Combination Regimen as an All-Oral Fixed-Duration Treatment Demonstrated Superior Progression-Free Survival in Adult Patients with Previously Untreated Chronic Lymphocytic Leukemia
GLOW study presented as a late-breaking abstract at the European Hematology Association (EHA) Virtual Congress
Janssen Announces Results from Phase 3 MAIA Study Showing Significant Overall Survival Benefits for Treatment with DARZALEX® (daratumumab) in Patients with Newly Diagnosed Multiple Myeloma Who are Transplant Ineligible
After nearly five years of follow-up, median progression-free survival was not reached, and a significant overall survival benefit was observed; data will be presented as a late-breaking abstract at the European Hematology Association (EHA) Virtual Congress
Janssen Highlights Commitment to Advancing Transformative Innovations in Oncology with Scientific Updates from Deep, Diverse Pipeline and Portfolio at ASCO and EHA Virtual Scientific Programs
- Clinical Data from More Than 10 Approved and Investigational Treatments for Solid Tumors and Hematologic Malignancies to be Presented During the 2021 ASCO Annual Meeting - Multiple Myeloma and Chronic Lymphocytic Leukemia Data to be Featured During EHA 2021 Virtual Congress
Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for Teclistamab for the Treatment of Relapsed or Refractory Multiple Myeloma
U.S. Milestone Follows European Medicines Agency PRIME Designation for this BCMA Bispecific Antibody for the Treatment of Relapsed or Refractory Multiple Myeloma
Janssen Reports New Data for BCMA CAR-T, Cilta-Cel, Showing Deep and Durable Responses in Patients with Relapsed or Refractory Multiple Myeloma
Eighteen-month follow-up from pivotal CARTITUDE-1 study, including progression-free-survival data, to be presented at ASCO and EHA Annual Meetings Findings from the Phase 2 CARTITUDE-2 study will be presented for the first time
Long-Term ERLEADA® (apalutamide) Patient-Reported Outcomes Data in Metastatic Castration-Sensitive Prostate Cancer Demonstrate Maintenance of Health-Related Quality of Life for Patients
Results at ASCO from Phase 3 TITAN study final analysis confirm survival benefit achieved with the addition of ERLEADA® to androgen deprivation therapy without significant side effect burden
Updated Data Demonstrate Significant Improvement in Hematologic Complete Response with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in Patients with Newly Diagnosed Light Chain (AL) Amyloidosis
Further analysis from the Phase 3 ANDROMEDA study presented at the 2021 ASCO Annual Meeting also show doubling rates of organ response with no new safety signals for the first FDA-approved treatment in a rare blood cell disorder
Janssen Presents Updated Data on First-in-Class Talquetamab at ASCO Suggesting Deep and Durable Responses in Heavily Pretreated Patients with Multiple Myeloma
Results from Phase 1 study of novel GPRC5DxCD3 T-cell redirecting bispecific antibody demonstrate promising clinical activity and support recommended Phase 2 dose
Janssen’s Updated Phase 1 Results for Teclistamab Suggest Deep, Durable Responses in Patients with Heavily Pretreated Multiple Myeloma
Subcutaneous administration of BCMAxCD3 T-cell redirecting bispecific antibody demonstrated clinical activity and a promising safety profile according to new data at ASCO
RYBREVANTTM (amivantamab-vmjw) Receives FDA Approval as the First Targeted Treatment for Patients with Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
RYBREVANTTM is the first fully-human, bispecific antibody approved in lung cancer Simultaneous FDA approval of a companion diagnostic aids in the identification of exon 20 insertion mutations
IMBRUVICA® (ibrutinib)-Based Combination Regimen as a Fixed-Duration, First-Line Treatment for Chronic Lymphocytic Leukemia Demonstrates High Rates of Disease Control
Janssen presents new data at ASCO showing efficacy of IMBRUVICA® plus venetoclax (CAPTIVATE study) in previously untreated patients with chronic lymphocytic leukemia, and up to seven-year follow-up results (RESONATE-2 study) on progression-free and overall survival benefits with single-agent IMBRUVICA®
Updated Amivantamab and Lazertinib Combination Data Demonstrate Durable Responses and Clinical Activity for Osimertinib-Relapsed Patients with EGFR-Mutated Non-Small Cell Lung Cancer
Findings to be presented at the ASCO Annual Meeting show preliminary efficacy in patients with EGFR-mutated NSCLC and Janssen’s commitment to address the need for new targeted therapies for this patient population Janssen to also present data comparing amivantamab monotherapy and real-world therapies in patients with NSCLC with EGFR exon 20 insertion mutations who have progressed after platinum doublet chemotherapy
Janssen Announces Treatment with ERLEADA® (apalutamide) Significantly Improved Overall Survival in Patients with Metastatic Castration-Sensitive Prostate Cancer
Final analysis from Phase 3 TITAN study demonstrated ERLEADA® provided statistically significant overall survival benefit and consistent safety profile in patients with advanced prostate cancer, regardless of extent of disease
Janssen Presents Results from Phase 3 ACIS Study in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with ERLEADA® (apalutamide) and ZYTIGA® (abiraterone acetate) Combination
ACIS study meets primary endpoint of improving time to radiographic progression or death in patients with advanced disease
New Amivantamab Data from CHRYSALIS Study Show Robust Clinical Activity and Durable Responses in Patients with Metastatic or Unresectable Non-Small Cell Lung Cancer and EGFR Exon 20 Insertion Mutations
Data presented have been submitted to U.S. and EU regulatory agencies and represent an important step towards addressing the high unmet need in this patient population
Janssen to Highlight Commitment to Lung Cancer Science and Innovation with Eight Data Presentations at the International Association for the Study of Lung Cancer’s 2020 World Conference on Lung Cancer
Updated amivantamab data from the Phase 1 CHRYSALIS study and new data characterizing the high unmet need among patients with non-small cell lung cancer (NSCLC) and EGFR exon 20 insertion mutations to be presented
