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20170627 |
ÁøÇ༺ ¾Ç¼º °íÇü¾Ï¿¡ ´ëÇÑ °íÁ¤ ¿ë·® Durvalumab + Tremelimumab º´¿ë¿ä¹ý ¶Ç´Â Durvalumab ´Üµ¶ ¿ä¹ýÀÇ ¶óº§ °ø°³, ´Ù±â°ü, ¾ÈÀü¼º ÀÓ»ó½ÃÇè (STRONG) |
3b»ó |
MEDI4736
MEDI1123 |
Çѱ¹¿¥¿¡½ºµð(À¯) |
20170627 |
ÁøÇ༺ °íÇü¾Ï ȯÀÚ¸¦ ´ë»óÀ¸·Î ´Üµ¶¿ä¹ýÀ¸·Î ±×¸®°í pembrolizumab°úÀÇ º´¿ë¿ä¹ýÀ¸·Î Åõ¿©ÇÑ MK-4280À» Æò°¡ÇÏ´Â Á¦1»ó ÀÓ»ó½ÃÇè |
1»ó |
MK-4280
Pembrolizumab |
Çѱ¹¿¥¿¡½ºµð(À¯) |
201706278 |
Àç¹ß¼º ¶Ç´Â ºÒÀÀ¼º ÀüÇüÀû È£ÁöŲ ¸²ÇÁÁ¾ ȯÀÚ¸¦ ´ë»óÀ¸·Î PembrolizumabÀ» Brentuximab Vedotin°ú ºñ±³ÇÏ´Â Á¦III»ó, ¹«ÀÛÀ§¹èÁ¤, ¶óº§-°ø°³ ÀÓ»ó½ÃÇè |
3»ó |
MK-3475 |
»ï¼º¼¿ïº´¿ø |
20170628 |
Etoposide+cisplatin¿¡ ½ÇÆÐÇÑ ÈÄ ÀüÀ̼º À§¼ÒÀå-ÃéÀå (GEP) ½Å°æ³»ºÐºñ ¾ÏÁ¾ (NEC, WHO 3µî±Þ)ÀÇ ÀÌÂ÷ Ä¡·á·Î¼ avelumabÀÇ Á¦II»ó ÀÓ»ó½ÃÇè: ¿¹ÃøÀû ºÐÀÚ ¾ÆÇüÀ» È®ÀÎÇϱâ À§ÇÑ À¯Àüü ºÐ¼®ÀÇ ÅëÇÕ |
2»ó |
MSB0010718C |
Çѱ¹³ë¹ÙƼ½º(ÁÖ) |
20170629 |
È°µ¿¼º °Ç¼±¼º °üÀý¿° ȯÀÚ¿¡°Ô ÇÇÇÏ Åõ¿©ÇÑ secukinumab ´Üµ¶ ¿ä¹ý°ú ÇÇÇÏ Åõ¿©ÇÑ adalimumab ´Üµ¶ ¿ä¹ýÀÇ Á¦ 52
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3b»ó |
AIN457 |
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FDA |
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Drug Name and
FDA Appl. # |
Active Ingredients |
Submission
Classification |
Company |
Approval Date |
TRIPTODUR
NDA #208956 |
TRIPTORELIN |
½ÅÁ¦Çü ¶Ç´Â
½ÅÁ¦Á¶¿ø |
ARBOR PHARMS INC |
06/29/2017 |
EFAVIRENZ, LAMIVUDINE,
AND TENOFOVIR DISOPROXIL FUMARATE
NDA #204119 |
EFAVIRENZ
LAMIVUDINE
TENOFOVIR DISOPROXIL FUMARATE |
½Å¿ë·® |
HETERO DRUGS LTD |
06/30/2017 |
PANTOPRAZOLE SODIUM
NDA #209463 |
PANTOPRAZOLE SODIUM |
½ÅÁ¦Çü ¶Ç´Â
½ÅÁ¦Á¶¿ø |
EXELA PHARMA
SCS LLC |
06/30/2017 |
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EMA |
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Name |
Active Substance |
Therapeutic areaCompany |
Date of authorisation
/refusal |
Ucedane |
carglumic acid |
Amino Acid Metabolism, Inborn Errors
Hyperammonemia |
23/06/2017 |
Kevzara |
sarilumab |
Arthritis, Rheumatoid |
23/06/2017 |
Erelzi |
etanercept |
Arthritis, Juvenile Rheumatoid
Arthritis, Psoriatic
Arthritis, Rheumatoid
Psoriasis |
23/06/2017 |
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Clinical.gov ¹Ì±¹ |
NCT
Number |
Title |
Conditions |
Interventions |
Sponsor
/Collaborators |
Phases |
NCT03206073 |
A Phase I/II Study of Pexa-Vec Oncolytic Virus in Combination With Immune Checkpoint Inhibition in Refractory Colorectal Cancer |
Colorectal Cancer
Microsatellite-
Stable (MSS) Tumor
Metastatic Disease |
Drug: Durvalumab
Drug: Tremelimumab
Biological: Pexa-Vec |
National Cancer Institute (NCI)
National Institutes of Health Clinical Center (CC) |
Phase 1
Phase 2 |
NCT03206047 |
Atezolizumab, Guadecitabine, and CDX-1401 Vaccine in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer |
Recurrent Fallopian Tube Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Primary Peritoneal Carcinoma |
Drug: Atezolizumab
Biological: DEC-205/NY-ESO-1 Fusion Protein CDX-1401
Drug: Guadecitabine
Other: Laboratory Biomarker Analysis
Drug: Poly ICLC |
National Cancer Institute (NCI) |
Phase 1
Phase 2 |
NCT03205644 |
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)
COG Phase
Consortium |
Phase 1
Phase 2 |
NCT03207542 |
Trial Evaluating the Efficacy and Safety of Daratumumab in Subjects With Relapsed/Refractory B-cell or T-cell Precursor Acute Lymphoblastic Leukemia (ALL) |
Malignant Neoplasms Stated as Primary Lymphoid Haematopoietic |
Drug: Daratumumab |
M.D. Anderson Cancer Center
Janssen Scientific Affairs, LLC |
Phase 2 |
NCT03205891 |
Study of Brentuximab Vedotin Plus TAK228 for Relapsed/Refractory Classical Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma and Other CD30+Peripheral T-Cell Lymphomas |
Malignant Neoplasms Stated as Primary Lymphoid Haematopoietic|Classical Hodgkin Lymphoma|Anaplastic Large Cell Lymphoma|CD30+ Peripheral T-cell Lymphoma |
Drug: Brentuximab Vedotin
Drug: TAK228
Device: Glucose Monitor |
M.D. Anderson Cancer Center
Takeda |
Phase 1 |
NCT03202628 |
Ixazomib Citrate, Pomalidomide, Dexamethasone, and Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Multiple Myeloma |
Recurrent Plasma Cell Myeloma
Refractory Plasma Cell Myeloma |
Procedure: Autologous Hematopoietic Stem Cell Transplantation
Drug: Dexamethasone
Drug: Ixazomib Citrate
Other: Laboratory Biomarker Analysis
Drug: Pomalidomide |
Mayo Clinic|National Cancer Institute (NCI) |
Phase 2 |
NCT03203304 |
Study of Stereotactic Body Radiotherapy (SBRT) Followed by Nivolumab or Ipilimumab With Nivolumab in Unresectable Hepatocellular Carcinoma |
Hepatocellular Carcinoma |
Drug: Nivolumab
Drug: Ipilimumab |
University of Chicago |
Phase 1 |
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Clinical.gov À¯·´ |
NCT
Number |
Title |
Conditions |
Interventions |
Sponsor
/Collaborators |
Phases |
NCT03203421 |
A Safety and Efficacy Study of ChAdOx1 LS2 |
Malaria |
Biological: ChAdOx1 LS2 |
University of Oxford |
Phase 1
Phase 2 |
NCT03202368 |
An Extension Study to Evaluate Long-Term Safety of Subcutaneous (SC) Tocilizumab in Participants With Giant Cell Arteritis (GCA) |
Giant Cell Arteritis |
Drug: Tocilizumab |
Hoffmann-La Roche |
Phase 3 |
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Clinical.gov Áß±¹ |
NCT
Number |
Title |
Conditions |
Interventions |
Sponsor
/Collaborators |
Phases |
NCT03205930 |
Neo-MASCT Immunotherapy for Advanced NSCLC |
NSCLC Stage IV
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Biological:
Neo-MASCT |
The First People's Hospital of Lianyungang
HengRui YuanZheng Bio-Technology Co.,Ltd. |
Phase 1
Phase 2 |
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Clinical.gov ÀϺ» |
NCT
Number |
Title |
Conditions |
Interventions |
Sponsor
/Collaborators |
Phases |
NCT03203876 |
A Safety Study of Lirilumab in Combination With Nivolumab or in Combination With Nivolumab and Ipilimumab in Advanced and/or Metastatic Solid Tumors |
Advanced Cancer |
Biological: Lirilumab
Biological: Nivolumab
Biological: Ipilimumab |
Bristol-Myers Squibb
Ono Pharmaceuticals |
Phase 1 |
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