相关临床试验
193
40 进行中
药物批准
50
批准总数
监管机构
2
监管机构数
成立时间
N/A
进行中（未招募）
16
8.3%
已完成
111
57.5%
尚未招募
24
12.4%
招募中
31
16.1%
撤回
11
5.7%
- Bristol Myers Squibb's subsidiary 2seventy bio has filed a patent infringement lawsuit against Johnson & Johnson and Legend Biotech at the Unified Patent Court, targeting their CAR-T cell therapy Carvykti. - The dispute centers on European patent EP 3 689 383, which protects a chimeric antigen receptor targeting B-cell maturation antigens, with both companies' therapies treating multiple myeloma. - This marks the first pharmaceutical case for the Brussels local division of the UPC and represents the growing trend of biotech patent disputes at the European court. - Parallel revocation proceedings have been initiated in the UK, while the patent remains under opposition at the European Patent Office, indicating a multi-jurisdictional battle over this critical cancer therapy technology.
- Janssen-Cilag applied to the European Medicines Agency to expand AKEEGA usage for adults with metastatic hormone-sensitive prostate cancer who have homologous recombination repair gene alterations. - Over 20% of mHSPC patients have HRR gene alterations, including BRCA1/2 genes, and these patients often experience worse outcomes with limited treatment options. - The application is supported by Phase 3 AMPLITUDE study results showing the niraparib and abiraterone acetate combination significantly delayed cancer progression and symptom worsening. - AKEEGA combines niraparib and abiraterone acetate, targeting a specific patient population with genetic changes that affect DNA repair mechanisms.
- The European Commission has approved Darzalex subcutaneous formulation (SC) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for newly diagnosed multiple myeloma (NDMM) patients eligible for autologous stem cell transplant (ASCT). - The approval is based on the Phase 3 PERSEUS study, which demonstrated a 58% reduction in the risk of disease progression or death compared to VRd alone. - The Darzalex regimen led to deeper responses, with a minimal residual disease (MRD) negativity rate of 75.2%. - This approval marks a significant advancement in frontline therapy, aiming to transform outcomes and establish new standards of care for eligible NDMM patients.
- A new European study finds patients with myasthenia gravis wait an average of 363 days for accurate diagnosis, with over 27% experiencing delays exceeding one year. - Patients with diagnostic delays over one year showed higher rates of MGFA class III disease, increased fatigue, anxiety, and depression compared to those diagnosed within a year. - The study spanning five European countries reveals 69.2% of patients with extended delays received incorrect initial diagnoses, highlighting urgent need for improved diagnostic strategies.
- The DREAMM-7 study demonstrated that belantamab mafodotin, bortezomib, and dexamethasone (BVd) significantly improved progression-free survival in relapsed/refractory multiple myeloma patients compared to daratumumab, bortezomib, and dexamethasone (DVd). - Median progression-free survival was 36.6 months in the BVd arm versus 13.4 months in the DVd arm (HR = 0.41; P < .0001), with consistent benefits across subgroups, including lenalidomide-refractory and high-risk cytogenetic myeloma. - An early, strong trend toward better overall survival was observed with BVd (HR = 0.57; P = .00049), alongside a doubling in response rates and undetectable measurable residual disease. - While ocular adverse effects were more frequent with BVd, they were generally manageable and reversible, suggesting BVd as a potential new standard of care in second-line or later relapsed/refractory multiple myeloma.
• The UK's healthcare cost-effectiveness agency NICE has rejected Johnson & Johnson's nasal spray antidepressant Spravato for NHS funding, citing concerns over its £10,500 per course price tag and clinical evidence gaps. • NICE highlighted uncertainties about Spravato's long-term efficacy maintenance and lack of comparative data against existing treatments like ECT and psychological therapies for treatment-resistant depression. • Janssen-Cilag, J&J's pharmaceutical unit, criticized the decision, arguing it could deny access to a needed treatment option for patients with treatment-resistant major depressive disorder, affecting up to 30% of depression cases.
