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б 20170623 ߼ / ̼ ΰ Ǿ ȯڸ ߷ʰ ġ ߷ ƮḮ¸ ġ 2 ӻ 2 MEDI4736,
Tremelimumab

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ŸƮųڸ() 20170620 ߼ Ǵ ̼ ΰ Ǽ ġḦ Ѹָ Ż ķ 1b/3 ٱ, ӻ 1/3 Ż ķ (Talimogene Laherparepvec)
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FDA
Drug Name and
FDA Appl. #
Active Ingredients Submission
Classification
Company Approval Date
COTEMPLA XR-ODT
NDA #205489
METHYLPHENIDATE ſ뷮 NEOS THERAP INC 06/19/2017
MYDAYIS
NDA #022063
MIXED SALTS OF A SINGLE-ENTITY AMPHETAMINE ſ뷮 SHIRE DEV LLC 06/20/2017
RITUXAN HYCELA
BLA #761064
HYALURONIDASE
RITUXIMAB
- GENENTECH INC 06/22/2017
BEVYXXA
NDA #208383
BETRIXABAN Ź PORTOLA PHARMA INC 06/23/2017
EMA
Name Active Substance Therapeutic areaCompany Date of authorisation
/refusal
Spinraza nusinersen sodium Muscular Atrophy, Spinal 30/05/2017
Brineura cerliponase alfa Neuronal Ceroid-Lipofuscinoses 30/05/2017
Elmiron pentosan polysulfate sodium Cystitis, Interstitial 02/06/2017
Clinical.gov ̱
NCT
Number
Title Conditions Interventions Sponsor
/Collaborators
Phases
NCT03197506 Pembrolizumab and Standard Therapy in Treating Patients With Glioblastoma

Glioblastoma
Gliosarcoma
Supratentorial Glioblastoma

Radiation: External Beam Radiation Therapy
Other: Laboratory Biomarker Analysis
Biological: Pembrolizumab
Radiation: Radiation Therapy
Drug: Temozolomide
Procedure: Therapeutic
Conventional Surgery

Mayo Clinic
National Cancer Institute (NCI)
Phase 2
NCT03197025 Immunotherapy With
E6 T Cell Receptor (TCR)
T Cells for Vulvar High-Grade Squamous Intraepithelial Lesions
Human Papillomavirus
HPV-16
High Grade Squamous Intraepithelial Lesion
Drug: Aldesleukin
Biological: E6 TCR
Memorial Sloan Kettering Cancer Center
Y-Mabs, Inc
Phase 1
NCT03196232 Epacadostat and Pembrolizumab in Treating Patients With Metastatic or Unresectable Gastroesophageal Junction or Gastric Cancer Gastric Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Recurrent Esophageal Carcinoma
Recurrent Gastric Carcinoma
Stage IV Esophageal Cancer AJCC v7
Stage IV Gastric Cancer AJCC v7
Unresectable Esophageal Carcinoma

Drug: Epacadostat
Other: Laboratory
Biomarker Analysis
Biological: Pembrolizumab

Pamela L. Kunz
Stanford University
Phase 2
NCT03196401 A Study of Immunotherapy Plus Radiation Therapy to Stimulate Immunity in Solitary Bone Plasmacytoma Solitary Bone Plasmacytoma Biological: Peri-urethral and clitoral injections Center for Vulvovaginal Disorders Phase 2
NCT03197935 A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer Triple-negative
Breast Cancer
Drug: Atezolizumab (MPDL3280A),
an engineered anti-PDL1 antibody
Drug: Placebo
Drug: Nab-paclitaxel
Drug: Doxorubicin
Drug: Cyclophosphamide
Drug: Filgrastim
Drug: Pegfilgrastim
Hoffmann-La Roche Phase 3
Clinical.gov
NCT
Number
Title Conditions Interventions Sponsor
/Collaborators
Phases
NCT03197467 Neoadjuvant Anti PD-1 Immunotherapy in Resectable Non-small Cell Lung Cancer Non-small Cell Lung Cancer (NSCLC) Drug: Pembrolizumab AIO-Studien-gGmbH|Merck Sharp & Dohme Corp. Phase 2
NCT03197935 A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer Triple-negative Breast Cancer Drug: Atezolizumab (MPDL3280A),
an engineered anti-PDL1 antibody
Drug: Placebo
Drug: Nab-paclitaxel
Drug: Doxorubicin
Drug: Cyclophosphamide
Drug: Filgrastim
Drug: Pegfilgrastim
Hoffmann-La Roche Phase 3
Clinical.gov ߱
NCT
Number
Title Conditions Interventions Sponsor
/Collaborators
Phases

NCT03198052

PSCA-CAR-T or MUC1-CAR-T for Cancer With PSCA/MUC1 Expression Lung Cancer
Cancer
Immunotherapy
CAR-T Cell
Genetic: PSCA or MUC1 targeting CAR-T cells Second Affiliated Hospital of Guangzhou Medical University Phase 1
NCT03196986 MIL60 Versus Bevacizumab in Patients With Treatment-naïve Non-squamous Non-small Cell Lung Cancer Non-small Cell Lung Cancer Drug: MIL60
Drug: Bevacizumab
Beijing Mabworks Biotech Co., Ltd. Phase 3
NCT03196830 CAR-T for R/R B-NHL Relapsed Non Hodgkin Lymphoma
Refractory Non-Hodgkin Lymphoma
CAR - T CD19/CD20/CD22/CD30
Biological: CAR-T The First Affiliated Hospital of Soochow University
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Phase 2
NCT03195491 A Study of Non-Small Cell Lung Cancer (NSCLC) Patients Receiving Second-Line Nivolumab Monotherapy in Asia Lung Cancer
Non-Small Cell Lung Cancer
Biological: Nivolumab Bristol-Myers Squibb Phase 3
NCT03195478 Study of Nivolumab in Combination With Ipilimumab in Chinese Subjects With Previously Treated Advanced or Recurrent Solid Tumors Solid Tumor Drug: Nivolumab
Drug: Ipilimumab
Bristol-Myers Squibb Phase 1
Clinical.gov Ϻ
NCT
Number
Title Conditions Interventions Sponsor
/Collaborators
Phases

NCT03197935

A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer Triple-negative Breast Cancer Drug: Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody
Drug: Placebo
Drug: Nab-paclitaxel
Drug: Doxorubicin
Drug: Cyclophosphamide
Drug: Filgrastim
Drug: Pegfilgrastim
Hoffmann-La Roche Phase 3
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281ȣ (2017.6.20)
Vol. 59 (July 3, 2017)

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