Janssen-Cilag International NV

Positive Phase 2/3 Vibrance-MG study results show nipocalimab plus standard of care (SOC) achieved sustained disease control in anti-AChR positive adolescents (12-17 years) with generalized myasthenia gravis (gMG), with significant IgG reduction and improvement in MG-ADL and QMG scores over 24 weeks.

Janssen-Cilag International NV submits Type II variation application to EMA for DARZALEX SC formulation in combination with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma, supported by Phase 3 CEPHEUS study data showing 60.9% MRD-negativity and 43% reduced risk of progression or death.

Janssen-Cilag International NV submits Type II variation application to EMA for DARZALEX® (daratumumab) SC formulation in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for newly diagnosed multiple myeloma (NDMM) patients not planning initial transplant. Data from Phase 3 CEPHEUS study shows D-VRd significantly improves MRD-negativity and reduces progression or death risk compared to standard VRd regimen.

The European Commission approves Yuvanci®, a single tablet combination therapy for PAH, marking the first such option in Europe. This approval is based on the Phase 3 A DUE study, which showed significant reductions in pulmonary vascular resistance compared to individual monotherapies. Yuvanci® addresses the unmet need for simplified PAH treatment regimens, aligning with ESC/ERS guidelines.

Updated RedirecTT-1 study results show high response rates and durable responses with a consistent safety profile for talquetamab and teclistamab combination in relapsed or refractory multiple myeloma patients, presented at the 2024 IMS Annual Meeting.

Janssen-Cilag announced updated Phase 1b RedirecTT-1 study results for TALVEY® and TECVAYLI® combination in RRMM patients, showing high response rates and durable responses with a manageable safety profile. The study highlights potential benefits for patients with extramedullary disease, offering a promising off-the-shelf treatment option.

Updated RedirecTT-1 study results show talquetamab and teclistamab combination yields high response rates and durable responses in relapsed or refractory multiple myeloma patients, with a safety profile consistent to each monotherapy.

Cilta-cel, a CAR-T therapy, showed a 45% reduction in death risk vs standard therapies for lenalidomide-refractory multiple myeloma patients, with significant overall survival improvement. Presented at the 2024 International Myeloma Society meeting, it marks a potential shift in treatment paradigms.

CHMP recommends daratumumab SC for newly diagnosed multiple myeloma patients eligible for ASCT, supported by PERSEUS study showing 60% reduction in disease progression or death risk with quadruplet therapy.