Oncology news archive
RYBREVANT ® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) show strong favorable overall survival trend versus osimertinib in EGFR-mutated advanced lung cancer
New longer-term data from the MARIPOSA study confirm superior outcomes of chemotherapyfree RYBREVANT® plus LAZCLUZE™ regimen compared to osimertinib monotherapy as firstline therapy Results from an interim analysis featured in late-breaker oral presentation at WCLC
European Commission approves RYBREVANT®▼ (amivantamab) in combination with chemotherapy for the treatment of adult patients with advanced EGFR-mutated non-small cell lung cancer after failure of prior therapy
Patients with EGFR ex19del or EGFR L858R mutations, the most common EGFR mutations in NSCLC, have until now faced a poor prognosis and limited treatment options after disease progression on an EGFR TKI1,2,3,4 Amivantamab in combination with chemotherapy is the first treatment regimen to show significant improvement in progression-free survival compared to chemotherapy alone in this patient population5
Johnson & Johnson is transforming solid tumor cancer outcomes with new data at the 2024 World Conference on Lung Cancer and European Society for Medical Oncology Congress
Four RYBREVANT® (amivantamab-vmjw) studies feature compelling new findings in lung and colorectal cancers New TAR-200 data reveal the potential of organ-sparing therapy for the treatment of bladder cancer
European Commission approves BALVERSA®▼ (erdafitinib) for adult patients with unresectable or metastatic urothelial carcinoma
First pan FGFR kinase inhibitor to be approved in the European Economic Area, for adults with unresectable or metastatic urothelial carcinoma and susceptible FGFR3 alterations Approval based on THOR results, showing 36 percent reduction in risk of death with erdafitinib versus chemotherapy1
RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) approved in the U.S. as a first-line chemotherapy-free treatment for patients with EGFR-mutated advanced lung cancer
RYBREVANT® plus LAZCLUZE™ is the first and only chemotherapy-free regimen showing superior progression-free survival versus osimertinib Following Priority Review, approval is based on Phase 3 MARIPOSA results showing RYBREVANT® plus LAZCLUZE™ reduced the risk of disease progression or death by 30 percent versus osimertinib, with a nine-month-longer median duration of response
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
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
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
Findings from landmark RESONATE-2 study confirm sustained survival benefit of IMBRUVICA® (ibrutinib) for first-line chronic lymphocytic leukaemia treatment with up to 10 years follow-up
RESONATE-2 data presented at the 2024 European Hematology Association (EHA) Congress provide longest-term outcomes and safety data ever reported for a monotherapy BTK inhibitor, with a median progression-free survival of 8.9 years1 Additional findings from pooled analysis of three Phase 3 studies showed treatment with ibrutinib has the potential to achieve comparable overall survival to the general European population2
Updated Phase 2 CAPTIVATE study results demonstrate sustained clinical benefit of fixed-duration IMBRUVICA® (ibrutinib) plus venetoclax as first-line treatment for patients with chronic lymphocytic leukaemia, including those with high-risk disease
At 5 years, 67 percent of patients were progression-free, with overall survival at 96 percent for all treated patients1
CARVYKTI® (ciltacabtagene autoleucel) significantly improved progression-free survival and deepened responses versus two standard therapies for patients with functional high-risk multiple myeloma
73 percent reduction in risk of disease progression or death seen with CARVYKTI® in the CARTITUDE-4 study in a subset of patients who had early relapse after initial multiple myeloma therapy1
DARZALEX® (daratumumab)-based regimens significantly improve clinical outcomes in both transplant-eligible and -ineligible patients who are newly diagnosed with multiple myeloma
88 percent of transplant-eligible patients achieved a complete response or better, and 47 percent of patients sustained MRD-negativity for longer than one year with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based induction, consolidation and maintenance regimens in the Phase 3 PERSEUS study 7.5 years median overall survival achieved with DARZALEX®-based regimen in Phase 3 MAIA final analysis is the longest reported in patients ineligible for transplant
Late-breaking results from PALOMA-2 study of subcutaneous amivantamab in combination with lazertinib show clinically meaningful antitumor response and improved safety profile in patients with EGFR-mutated non-small cell lung cancer
Significantly lower infusion-related reactions seen with subcutaneous amivantamab compared with intravenous administration in new Phase 2 data
TECVAYLI® (teclistamab-cqyv) shows sustained deep and durable responses in patients with relapsed or refractory multiple myeloma
New MajesTEC-1 data show a median duration of response of 24 months, with responses deepening, including in patients who switched to biweekly dosing1 Separate analyses from the MajesTEC-1 and OPTec studies are the first to underscore the opportunity for outpatient administration of TECVAYLI®
First results from late-breaking Phase 3 PALOMA-3 study show five-fold reduction in infusion-related reactions with five-minute subcutaneous amivantamab administration
New formulation showed non-inferiority to intravenous administration in fourth positive Phase 3 study in RYBREVANT® clinical program Longer overall survival, progression-free survival and duration of response shown with subcutaneous amivantamab; featured in Best of ASCO 2024 RYBREVANT® marketing application submitted to European Medicines Agency based on PALOMA-3 study
RYBREVANT® (amivantamab-vmjw) plus lazertinib is the only chemotherapy-free regimen showing longer progression-free survival versus osimertinib in first-line treatment of patients with high-risk EGFR-mutated non-small cell lung cancer
Investigational chemotherapy-free regimen of RYBREVANT® plus lazertinib addresses a significant unmet need as most patients with EGFR-mutated NSCLC have high-risk disease Landmark Phase 3 MARIPOSA data featured in an oral presentation at ASCO
