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Delcath Systems / Inc. / Hepatocellular carcinoma / Uveal melanoma / Ipilimumab / Immunotherapy / End point of clinical trials / DecisionDx-UM / Sunitinib / Medicine / Hepatology / Melanoma


FDA Briefing Document Oncologic Drugs Advisory Committee Meeting May 2, 2013 NDA[removed] – 001 Melblez Kit Delcath Systems, Inc.
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City

Newtown / /

Company

NCI / Bioclinica Inc / Melblez Kit Delcath Systems Inc. / /

Event

FDA Phase / Business Partnership / /

Facility

University of Pittsburgh Medical Center / National Cancer Institute / John Wayne Cancer Institute / /

IndustryTerm

nonNCI site / treatment of hepatic tumors secondary to melanoma / cancer treatment / parallel / treatment of patients with metastatic melanoma / melanoma site / drug/device combination product / treatment of patients with unresectable or metastatic melanoma / tumor site / treatment of metastatic or unresectable melanoma / treatment of patients with cutaneous melanoma / treatment of melanoma / patient management / healthcare providers prescribing / combination product / treatment of patients with unresectable metastatic ocular melanoma / investigational site / melanoma prior site / treatment of metastatic cancer / healthcare providers / therapies for metastatic ocular melanoma / /

MedicalCondition

ocular melanomas / hepatic melanoma disease / hepatic-dominant / metastatic ocular melanoma / such changes Background Indicated Population Ocular melanoma / metastatic ocular melanoma / hepatic-dominant metastatic ocular melanoma / skin/subcutaneous metastases / ocular melanoma / Solid Tumors / metastatic ocular melanoma comparing / cirrhosis / severe hypotension / metastatic disease / hepatic metastases / hepaticdominant metastatic disease arising / extrahepatic disease progression requiring systemic therapy / melanoma / gastrinoma / gastrointestinal hemorrhage / metastatic melanoma arising / arterial spasm / disorder / early stage disease / pulmonary nodules / infections / hepatic disease / streptococcal sepsis / tumor / congestive heart failure / unresectable melanoma / tumors / disease / primary cancers / metastatic cutaneous melanoma / primary hepatic cancers / neutropenic fever / hepatic tumors / common primary intraocular malignant tumor / progressive disease / stroke / previously untreated metastatic ocular melanoma / chronic anticoagulation / myocardial infarction / metastatic cancer / portal hypertension / hepatic failure / chronic pulmonary restrictive disease / chronic obstructive pulmonary disorder / stable disease / cutaneous melanoma / documented hepatic disease / limited / unresectable extrahepatic disease / Metastases / metastastic disease / objective tumor / hepatic melanoma / disorders / unresectable metastatic ocular melanoma / metastatic melanoma / primary tumor / /

MedicalTreatment

antineoplastic therapy / biologic therapy / chemotherapy / radiotherapy / embolization / hemoperfusion / catheter / catheters / bypass / cryotherapy / hemofiltration / /

Organization

National Cancer Institute / FDA Briefing Document Oncologic Drugs Advisory Committee / Food and Drug Administration / FDA’s office of Combination Products / American Society of Clinical Oncology / University of Pittsburgh / Review Division / Oncologic Drugs Advisory Committee / Center for Drug Evaluation and Research / Advisory Committee / Pittsburgh Medical Center / John Wayne Cancer Institute / /

Person

Van Raamsdonk / /

Position

investigator / referring physician / treating physician / Major / medical officer / /

Product

Alkeran / Proleukin / TACE / DTIC-Dome / dacarbazine / Center / Melblez Kit / Zelboraf® / V600E / C-0088 / Applicant / /

ProvinceOrState

Connecticut / /

Technology

Radiation / MRI / chemotherapy / /

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