Oncology news archive
CHMP recommends RYBREVANT®▼ (amivantamab) in combination with LAZCLUZE®▼ (lazertinib) for the first-line treatment of patients with EGFR-mutated advanced non-small cell lung cancer
The amivantamab plus lazertinib combination regimen offers potential to provide new standard of care as first-line option for adult patients with advanced NSCLC with EGFR ex19del or L858R substitution mutations1 In the Phase 3 MARIPOSA study, amivantamab plus lazertinib significantly reduced risk of disease progression or death by 30 percent versus osimertinib monotherapy1
Johnson & Johnson submits applications in the U.S. and EU seeking approval of DARZALEX FASPRO® / DARZALEX® as subcutaneous monotherapy for high-risk smoldering multiple myeloma
If approved, DARZALEX FASPRO® will become the first treatment option for patients with smoldering multiple myeloma at high-risk of developing multiple myeloma, offering a novel approach to treat before the onset of active disease and the occurrence of end organ damage
DARZALEX® (daratumumab)-SC based quadruplet regimen approved by the European Commission for patients with newly diagnosed multiple myeloma who are transplant-eligible
Phase 3 PERSEUS study of daratumumab subcutaneous (SC) formulation in combination with bortezomib, lenalidomide and dexamethasone induction and consolidation, followed by daratumumab SC and lenalidomide maintenance showed a 58 percent reduction in risk of disease progression or death1 New regimen reinforces daratumumab SC as a foundational element for optimising frontline treatment of patients with newly diagnosed multiple myeloma, and significantly delaying disease progression2
Johnson & Johnson submits application to the European Medicines Agency for DARZALEX® (daratumumab) SC-based quadruplet regimen for newly diagnosed multiple myeloma patients
Submission supported by data from the Phase 3 CEPHEUS study for the treatment of patients with newly diagnosed multiple myeloma for whom transplant is not planned as initial therapy.1 Data showed that the daratumumab subcutaneous formulation-based quadruplet regimen significantly improved minimal residual disease (MRD)-negativity and reduced the risk of progression or death compared to standard of care regimen.1
ERLEADA® (apalutamide) demonstrates statistically significant and clinically meaningful improvement in overall survival compared to enzalutamide in patients with metastatic castration-sensitive prostate cancer
Largest head-to-head real-world study in mCSPC demonstrated that ERLEADA® reduced risk of death by 23 percent at 24 months compared to enzalutamide
Johnson & Johnson files for U.S. FDA approval of DARZALEX FASPRO®-based quadruplet regimen for newly diagnosed multiple myeloma patients for whom transplant is not planned
Results from CEPHEUS study highlight DARZALEX FASPRO® quadruplet regimen as a potential standard of care in newly diagnosed patients regardless of transplant eligibility New indication would be the first FDA-approved treatment regimen for newly diagnosed multiple myeloma based on a study with MRD-negativity as the primary endpoint
Johnson & Johnson to invest more than $2 billion in new, advanced technology manufacturing facility in North Carolina to support robust portfolio growth
Johnson & Johnson (NYSE: JNJ) today announced an investment of more than $2 billion to build a state-of-the-art biologics manufacturing facility in Wilson, North Carolina. The new facility will expand production of the Company’s portfolio and pipeline of innovative biologics in support of Johnson & Johnson’s broader plan to advance more than 70 novel therapy and product expansion filings and launches by the end of the decade.
CARVYKTI® is the first and only cell therapy to significantly extend overall survival versus standard therapies for patients with multiple myeloma as early as second line
45 percent reduction in risk of death achieved with CARVYKTI® after three-year follow-up in landmark CARTITUDE-4 study Data featured in a late-breaking oral presentation at the 2024 International Myeloma Society Annual Meeting
DARZALEX® (daratumumab)-based maintenance regimens show clinically meaningful deep and durable responses in transplant-eligible patients with newly diagnosed multiple myeloma
Minimal residual disease (MRD)-negativity rate of 10-5 more than doubled by 12 months with DARZALEX FASPRO® in maintenance therapy compared to lenalidomide alone, resulting in improvement in 30-month progression-free survival
DARZALEX FASPRO®-based quadruplet regimen significantly improves minimal residual disease negativity for newly diagnosed multiple myeloma patients for whom transplant is not planned
Study of the first and only subcutaneous quadruplet regimen demonstrates 60.9 percent improvement in minimal residual disease (MRD)-negativity and 43 percent reduction in the risk of progression or death Phase 3 CEPHEUS study results presented in late-breaking oral presentation at the International Myeloma Society (IMS) Annual Meeting
TALVEY® (talquetamab-tgvs) and DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) based combination shows deep and durable responses in patients with relapsed or refractory multiple myeloma
Updated data show 100 percent overall response rate with 56 percent of patients achieving complete response or better with weekly dosing, supporting the combinability of the GPRC5D bispecific antibody Safety profile, including infection rates, similar to TALVEY® and DARZALEX FASPRO® monotherapies
Novel combination of TALVEY® (talquetamab-tgvs) and TECVAYLI® (teclistamab-cqyv) suggests high response rates and durable responses in triple-class refractory patients with relapsed or refractory multiple myeloma, including those with extramedullary disease
Data from the investigational Phase 1b RedirecTT-1 study demonstrate a safety profile consistent to TALVEY® and TECVAYLI® monotherapies
DARZALEX® (daratumumab)-based quadruplet regimen receives positive CHMP opinion for transplant-eligible patients with newly diagnosed multiple myeloma
Recommendation supported by findings from quadruplet therapy PERSEUS study with daratumumab subcutaneous (SC) formulation in the frontline setting Findings showed 60 percent reduction in risk of disease progression or death with daratumumab SC quadruplet regimen compared to current standard of care triplet regimen1
RYBREVANT® (amivantamab-vmjw) plus standard of care approved in the U.S. as first and only targeted regimen to cut risk of disease progression by more than half in second-line EGFR-mutated advanced lung cancer
Approval based on compelling safety and efficacy from the Phase 3 MARIPOSA-2 study, marking the third new indication for RYBREVANT® this year, with four indications overall
Neoadjuvant TAR-200 plus cetrelimab nearly doubles the pathological complete response rate compared to cetrelimab alone in patients with muscle-invasive bladder cancer
TAR-200 plus cetrelimab effective in reducing tumor size in those with muscle-invasive disease, potentially improving surgical outcomes and lowering risk of recurrence
New data from TAR-200 Phase 2b SunRISe-1 study show 84 percent complete response rate in patients with high-risk non-muscle-invasive bladder cancer
Investigational TAR-200 monotherapy demonstrates high complete response rate without the need for reinduction or additive therapy in patients who are Bacillus Calmette-Guérin (BCG)-unresponsive
RYBREVANT® (amivantamab-vmjw) plus chemotherapy show 49 percent overall response rate in metastatic colorectal cancer
Median duration of response reaches 7.4 months with combination treatment in patients with aggressive form of disease New results show potential of RYBREVANT® beyond lung cancer
