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[국문] 298호 (2017.10.31.)

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작성일 2017-10-31 14:39:56
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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

▶식약처 원문 [Click]

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