Johnson & Johnson Innovative Medicine
Pharmaceutical Companies of Johnson and Johnson
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 chemotherapy 23 August 2024 -- Beerse, Belgium -- Janssen-Cilag International NV, a Johnson &...
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,...
Johnson & Johnson Receives Positive CHMP Opinion for Yuvanci® (Single Tablet Combination Therapy [STCT] of Macitentan and Tadalafil) for Treatment of Patients with Pulmonary Arterial Hypertension (PAH)
If approved, Yuvanci® would become the only single tablet combination for treatment for patients with PAH Johnson & Johnson’s comprehensive PAH portfolio has the potential to cover all guideline-recommended treatment pathways BEERSE, BELGIUM, July 26, 2024 (GLOBE NEWSWIRE) -- Janssen-Cilag International NV, a Johnson & Johnson company, announced today that the Committee for Medicinal Products...
RYBREVANT (amivantamab) in combination with chemotherapy is the first therapy approved by the European Commission for the first-line treatment of patients with advanced non-small cell lung cancer with activating EGFR exon 20 insertion mutations
Approval is supported by the phase 3 PAPILLON study, which showed amivantamab plus chemotherapy significantly reduced the risk of disease progression or death by 60% compared to chemotherapy alone 28 June 2024, Beerse, Belgium – Janssen-Cilag International NV, a Johnson & Johnson company, announced today that the European Commission (EC) has approved a type 2...
CHMP adopts positive opinion for BALVERSA (erdafitinib) for the treatment of adult patients with unresectable or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations
Pending approval, erdafitinib would become the first therapy targeting FGFR3 alterations in patients with metastatic urothelial carcinoma, one of Europe’s most common cancers The CHMP’s recommendation is based on results from Cohort 1 of the phase 3 THOR study, which showed a 36% reduction in the risk of death with erdafitinib versus chemotherapy. 28 June...
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 PFS of 8.9 years Additional findings from pooled analysis of three phase 3 studies show treatment with ibrutinib has the potential to achieve comparable overall survival to the...
TALVEY (talquetamab) demonstrated highly durable, longer-term responses in patients with relapsed or refractory multiple myeloma
24-month overall survival rate of 67% achieved with talquetamab 0.8mg/kg biweekly dosing in the phase 1/2 MonumenTAL-1 study 14 June 2024 – Beerse, Belgium – Janssen-Cilag International NV, a Johnson & Johnson company announced today that long-term data from the phase 1/2 MonumenTAL-1 study showed that with 20 to 30 months of median follow-up, triple...
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% of patients were progression-free, with overall survival at 96% for all treated patients 14 June 2024 – Beerse, Belgium – (GLOBE NEWSWIRE) – Janssen-Cilag International NV, a Johnson & Johnson company, today announced updated findings from the phase 2 CAPTIVATE study evaluating fixed-duration (FD) IMBRUVICA (ibrutinib) in combination with venetoclax (I+V)...
CARVYKTI▼ (ciltacabtagene autoleucel; cilta-cel) significantly improved progression-free survival and deepened responses versus two standard therapies for patients with functional high-risk multiple myeloma
73% reduction in risk of disease progression or death seen with cilta-cel in the CARTITUDE-4 study in a subset of patients who had early relapse after initial multiple myeloma therapy 3 June 2024 -- Beerse, Belgium -- Janssen-Cilag International, a Johnson & Johnson company announced today results from a subgroup analysis of the phase 3...
TECVAYLI▼ (teclistamab) 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 dosing Separate analyses from the MajesTEC-1 and OPTec studies are the first to underscore the opportunity for outpatient administration of teclistamab. 3 June 2024 -- Beerse, Belgium -- Janssen-Cilag International NV, a Johnson...
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