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[국문] 298호 (2017.10.31.)
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입법예고 「유전자치료제 비임상시험 평가 가이드라인」 제정안 의견조회

1. 제정이유 
유전자치료제 개발 시 필요한 비임상시험 고려사항을 제시

2. 주요내용
유전자치료제의 경우 다른 생물의약품과 달리 제품의 특성상 인체 유전자 내로의 삽입가능성, 벡터의 복제가능성 등 안전성과 관련된 특성이 있어 본 가이드라인에서 유전자치료제 특이적인 비임상시험 자료 작성을 위한 상세한 평가원칙을 제공

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입법예고 「인유두종바이러스 백신 허가·심사 가이드라인」제정(안)에 대한 의견조회

1. 제정이유 
인유두종바이러스 백신 연구․개발에 초석이 되고, 합리적이고 일관적인 백신의 허가․심사를 위한 국제 조화된 가이드라인을 제시

2. 주요내용
인유두종바이러스(Human Papilloma Virus; HPV) 백신의 제조와 품질평가, 비임상(독성 및 약리) 및 임상시험의 수행에 필요한 권고사항을 제공

식약처 원문[Click]

 
신청자 승인일 제품명 시험
제목
단계
삼성서울병원 20171030 4 cm 미만의 고형 또는 미세혈관 아형의 병리학적 병기 1기인 폐선암 환자에 대한 수술 후 펨브롤리주맙(상품명: 키트루다) 치료 2상 키트루다주
(MK-3475)
한국로슈 20171030 절제불가능한 진행성 및/또는 전이성 신세포암 환자에서 아테졸리주맙 ± 베바시주맙과 병용시 RO6874281의 안전성, 약물동태학 및 치료 활성을 평가하는 공개, 다기관, 무작위배정, 용량 증가, 제IB상 임상시험 1상 RO6874281
분당서울대학교병원 20171026 재발성 난소투명세포선암 환자에 대한 Durvalumab(MEDI4736)과 의사가 선택한 항암화학요법을 비교하는 다기관 제2상 무작위배정 시험 2b상 MEDI4736
   
미국      
Approval Date Drug Name Active Ingredients Submission Classification Company
10/20/2017 BYDUREON BCISE (exenatide extended-release) injectable suspension NDA #209210 EXENATIDE 신용량 ASTRAZENECA AB
10/20/2017 DAPTOMYCIN
NDA #209949
Daptomycin for Injection, 350 mg/vial. 신제형 또는 신제조원 XELLIA PHARMS APS
10/25/2017 VARUBI NDA #208399 ROLAPITANT 신용량 TESARO INC
10/30/2017 PREXXARTAN NDA #209139 VALSARTAN - CARMEL BIOSCIENCES INC
유럽      
Name Active Substance Therapeutic area Date of authorisation
/ refusal
Rydapt midostaurin Leukemia, Myeloid,
Acute Mastocytosis
18/09/2017
   
미국      
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
유럽      
NCT Number Title Conditions Interventions Sponsor/Collaborators Phases 비고
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 프랑스,
독일
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
독일
NCT03324282 First-line Gemcitabine/Cisplatin +/- Avelumab in Locally Advanced or Metastatic Bladder Carcinoma Bladder Carcinoma Drug: Avelumab|Drug: GC University Hospital, Bordeaux Phase 2 프랑스
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 프랑스
중국      
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
일본      
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
   
   
2017 (사)한국에프디시법제학회 추계학술대회
주제 건강보험 정책과 R&D, 그리고 규제과학
일시 및 장소  2017년 11월 9일 (목) 09:00~18:00 / 베스트웨스턴 프리미어 서울가든호텔
주최 (사)한국에프디시법제학회    
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