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Zﺴ 20171030 4 cm ̸ Ǵ ̼ 1 󼱾 ȯڿ Ѹָ(ǰ: ŰƮ) ġ 2 ŰƮ
(MK-3475)
ѱν 20171030 Ұ ༺ ףǴ ̼ ż ȯڿ ָ ٽָ RO6874281 , ๰ ġ Ȱ ϴ , ٱ, , 뷮 , IB ӻ 1 RO6874281
д缭б 20171026 ߼ ȯڿ Durvalumab(MEDI4736) ǻ簡 ׾ȭп ϴ ٱ 2 2b MEDI4736
   
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Approval Date Drug Name Active Ingredients Submission Classification Company
10/20/2017 BYDUREON BCISE (exenatide extended-release) injectable suspension NDA #209210 EXENATIDE ſ뷮 ASTRAZENECA AB
10/20/2017 DAPTOMYCIN
NDA #209949
Daptomycin for Injection, 350 mg/vial. Ǵ XELLIA PHARMS APS
10/25/2017 VARUBI NDA #208399 ROLAPITANT ſ뷮 TESARO INC
10/30/2017 PREXXARTAN NDA #209139 VALSARTAN - CARMEL BIOSCIENCES INC
     
Name Active Substance Therapeutic area Date of authorisation
/ refusal
Rydapt midostaurin Leukemia, Myeloid,
Acute Mastocytosis
18/09/2017
   
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NCT Number Title Conditions Interventions Sponsor/Collaborators Phases
NCT03325816 Nivolumab and 177Lu-DOTA0-Tyr3-Octreotate for Patients With Extensive-Stage Small Cell Lung Cancer Small Cell Lung Cancer|Small Cell Lung Cancer Extensive Stage Drug: Nivolumab|Radiation: 177Lu-DOTA0-Tyr3-Octreotate Giuseppe Giaccone|Bristol-Myers Squibb|Advanced Accelerator Applications|Georgetown University Phase 1
Phase 2
NCT03325101 Dendritic Cell Therapy After Cryosurgery in Combination With Pembrolizumab in Treating Patients With Stage III-IV Melanoma That Cannot Be Remove by Surgery Stage III Cutaneous Melanoma AJCC v7|Stage IIIA Cutaneous Melanoma AJCC v7|Stage IIIB Cutaneous Melanoma AJCC v7|Stage IIIC Cutaneous Melanoma AJCC v7|Stage IV Cutaneous Melanoma AJCC v6 and v7 Procedure: Cryosurgery|Biological: Pembrolizumab|Procedure: Pheresis|Biological: Therapeutic Autologous Dendritic Cells Mayo Clinic|National Cancer Institute (NCI) Phase 1
Phase 2
NCT03320330 VX15/2503 in Treating Younger Patients With Recurrent, Relapsed, or Refractory Solid Tumors Recurrent Malignant Solid Neoplasm|Recurrent Osteosarcoma|Refractory Malignant Solid Neoplasm Biological: Anti-SEMA4D Monoclonal Antibody VX15/2503|Other: Laboratory Biomarker Analysis|Other: Pharmacological Study Children's Oncology Group|National Cancer Institute (NCI) Phase 1
Phase 2
NCT03325465 Neoadjuvant Pembrolizumab + Epacadostat Prior to Curative Surgical Care for Squamous Cell Carcinoma of the Head and Neck Squamous Cell Carcinoma of the Head and Neck Drug: Pembrolizumab|Drug: Epacadostat University of Chicago Phase 2
NCT03325166 Pembrolizumab and Magnetic Resonance Imaging With Ferumoxytol in Treating Patients With Non-small Cell Lung Cancer and Brain Metastases Lung Carcinoma Metastatic in the Brain|PD-L1 Positive|Stage IV Non-Small Cell Lung Cancer AJCC v7 Drug: Ferumoxytol|Other: Laboratory Biomarker Analysis|Procedure: Magnetic Resonance Imaging|Biological: Pembrolizumab OHSU Knight Cancer Institute|National Cancer Institute (NCI) Phase 2
NCT03325075 Safety, Tolerability, and Immunogenicity of VAL-181388 in Healthy Subjects Chikungunya Virus Biological: VAL-181388|Other: Placebo Moderna Therapeutics|Defense Advanced Research Projects Agency Phase 1
NCT03323944 CAR T Cell Immunotherapy for Pancreatic Cancer Pancreatic Cancer|Cancer of the Pancreas Biological: huCART-meso cells University of Pennsylvania Phase 1
NCT03321643 Atezolizumab, Gemcitabine, Oxaliplatin, and Rituximab in Treating Patients With Relapsed or Refractory Transformed Diffuse Large B-Cell Lymphoma Recurrent Diffuse Large B-Cell Lymphoma|Refractory Diffuse Large B-Cell Lymphoma|Refractory Transformed Indolent Non-Hodgkin Lymphoma|Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma Drug: Atezolizumab|Drug: Gemcitabine|Other: Laboratory Biomarker Analysis|Drug: Oxaliplatin|Biological: Rituximab National Cancer Institute (NCI) Phase 1
NCT03321630 A Study of Lenvatinib, a Multi-targeted Tyrosine Kinase Inhibitor, Combined With Pembrolizumab (PD-1 Inhibitor) for the Treatment of Metastatic Gastroesophageal Cancer Patients Who Have Progressed on First or Subsequent Line Therapies GastroEsophageal Cancer Drug: Lenvatinib|Drug: Pembrolizumab New York University School of Medicine Phase 2
NCT03319745 A Window of Opportunity Study of Pembrolizumab in Patients With Bladder Cancer Undergoing Radical Cystectomy Malignant Neoplasms of Urinary Tract|Urothelial Carcinoma of the Bladder Drug: Pembrolizumab M.D. Anderson Cancer Center|Merck Sharp & Dohme Corp. Phase 2
NCT03319459 FATE-NK100 as Monotherapy and in Combination With Monoclonal Antibody in Subjects With Advanced Solid Tumors HER2 Positive Gastric Cancer|Colorectal Cancer|Head and Neck Squamous Cell Carcinoma|EGFR Positive Solid Tumor|Advanced Solid Tumors|HER2-positive Breast Cancer|Hepatocellular Carcinoma|Small Cell Lung Cancer|Renal Cell Carcinoma|Pancreas Cancer Drug: FATE-NK100|Drug: Cetuximab|Drug: Trastuzumab Fate Therapeutics Phase 1
NCT03323398 Dose Escalation Study of mRNA 2416 for Intratumoral Injection to Patients With Advanced Malignancies Relapsed/Refractory Solid Tumor Malignancies or Lymphoma Biological: mRNA-2416 Moderna Therapeutics Phase 1
NCT03321981 MCLA-128 With Trastuzumab/Chemotherapy in HER2+ and With Endocrine Therapy in ER+ and Low HER2 Breast Cancer Breast Cancer Metastatic Drug: MCLA-128|Drug: Trastuzumab|Drug: Vinorelbine|Drug: Endocrine therapy Merus N.V.|Oncology Therapeutic Development|Chiltern International Inc. Phase 2
     
NCT Number Title Conditions Interventions Sponsor/Collaborators Phases
NCT03325504 Open-label, Randomized, Study Comparing Cultured MSC Plus Biomaterial vs Iliac Crest Graft in Non-union Fractures Non Union Fracture Biological: Cultured Mesenchymal Cells|Procedure: Autologous iliac crest graft Universidad Autonoma de Madrid Phase 3 ,
NCT03325621 Phase 2a Study to Evaluate PRS-080 in Anemic Chronic Kidney Disease Patients Anemia of Chronic Kidney Disease Biological: PRS-080#022-DP|Biological: PRS-080-Placebo#001 Pieris Pharmaceuticals GmbH|FGK Clinical Research GmbH Phase 1
Phase 2
NCT03324282 First-line Gemcitabine/Cisplatin +/- Avelumab in Locally Advanced or Metastatic Bladder Carcinoma Bladder Carcinoma Drug: Avelumab|Drug: GC University Hospital, Bordeaux Phase 2
NCT03321981 MCLA-128 With Trastuzumab/Chemotherapy in HER2+ and With Endocrine Therapy in ER+ and Low HER2 Breast Cancer Breast Cancer Metastatic Drug: MCLA-128|Drug: Trastuzumab|Drug: Vinorelbine|Drug: Endocrine therapy Merus N.V.|Oncology Therapeutic Development|Chiltern International Inc. Phase 2
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NCT Number Title Conditions Interventions Sponsor/Collaborators Phases
NCT03322735 Study of BCMA CAR-T in Multiple Myeloma Multiple Myeloma Drug: Fludarabine
Drug: Cyclophosphamide
Biological: BCMA CAR-T
Henan Cancer Hospital
The Pregene (ShenZhen) Biotechnology Company, Ltd.
Phase 1
Phase 2
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NCT Number Title Conditions Interventions Sponsor/Collaborators Phases
NCT03324932 Efficacy of Denosumab on Normal BMD in Women Receiving Adjuvant Aromatase Inhibitors for Early Breast Cancer Breast Cancer Drug: Denosumab Injection Kyoto Prefectural University of Medicine Phase 3
NCT03324113 Evaluation of SAR408701 in Combination With Other Anti-tumor Drug in Japanese Patients With Advanced Malignant Solid Tumors Neoplasm Malignant Biological: SAR408701
Drug: trifluridine and tipiracil TAS-102
Drug: naphazoline
Drug: dexamethasone
Drug: diphenhydramine
Sanofi Phase 1
   
   
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297ȣ (2017.10.24.)
299ȣ (2017.11.7.)

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