Durvalumab - MedImmune

Drug Profile

Durvalumab - MedImmune

Alternative Names: Anti-PD-L1 monoclonal antibody; Anti-PD-LI mAb; Anti-programmed cell death 1 ligand 1 monoclonal antibody; Imfinzi; MEDI-4736

Latest Information Update: 13 Aug 2018

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At a glance

  • Originator MedImmune
  • Developer Advaxis; AIO Studien gGmbH; AstraZeneca; Big Ten Cancer Research Consortium; Canadian Cancer Trials Group; Case Comprehensive Cancer Center; Celgene International SARL; Centre Leon Berard; Charite - Universitatsmedizin Berlin; Childrens Hospital Los Angeles; Dana-Farber Cancer Institute; Eli Lilly; Fondazione IRCCS Istituto Nazionale dei Tumori; GlaxoSmithKline; Gradalis; Grand Hopital de Charleroi; Grupo Espanol de Tumores Neuroendocrinos; Gustave Roussy; Immunocore; Institut Claudius Regaud; Juno Therapeutics; Kyoto Breast Cancer Research Network; Ludwig Institute for Cancer Research; M. D. Anderson Cancer Center; MedImmune; Memorial Sloan-Kettering Cancer Center; Mirati Therapeutics; National Cancer Institute (USA); National Health and Medical Research Council; Northwestern University; Pharmacyclics; Plexxikon; Samsung Medical Center; Seoul National University Hospital; Swiss Group for Clinical Cancer Research; UNC Lineberger Comprehensive Cancer Center; University College London; University of Colorado at Denver; University of Maryland Greenbaum Cancer Center; University of Southern California; University of Sydney; University of Texas M. D. Anderson Cancer Center; VentiRx Pharmaceuticals; Washington University School of Medicine; Yale University; Yonsei University College of Medicine
  • Class Antineoplastics; Monoclonal antibodies
  • Mechanism of Action Programmed cell death-1 ligand-1inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Urogenital cancer
  • Registered Non-small cell lung cancer
  • Phase III Bladder cancer; Head and neck cancer; Hepatocellular carcinoma; Renal cell carcinoma; Small cell lung cancer; Solid tumours
  • Phase II/III Breast cancer; Gynaecological cancer; Pancreatic cancer
  • Phase II Acute myeloid leukaemia; Biliary cancer; Brain metastases; Cholangiocarcinoma; Colorectal cancer; Diffuse large B cell lymphoma; Endometrial cancer; Fallopian tube cancer; Gallbladder cancer; Gastric cancer; Germ cell and embryonal neoplasms; Glioblastoma; Mesothelioma; Multiple myeloma; Myelodysplastic syndromes; Neuroendocrine tumours; Oesophageal cancer; Ovarian cancer; Peritoneal cancer; Prostate cancer; Sarcoma; Soft tissue sarcoma
  • Phase I/II Cervical cancer; Chronic lymphocytic leukaemia; Cutaneous T cell lymphoma; Lung cancer; Lymphoma; Malignant melanoma; Non-Hodgkin's lymphoma; Peripheral T-cell lymphoma; Renal cancer
  • Phase I CNS cancer; Lymphoproliferative disorders; Myelofibrosis; Oropharyngeal cancer; Thyroid cancer; Vulvovaginal cancer

Most Recent Events

  • 02 Aug 2018 Phase-II clinical trials in Head and neck cancer (Combination therapy, Inoperable/Unresectable, First-line therapy) in Germany (IV) (EudraCT2016-003175-22)
  • 02 Aug 2018 Phase-I/II clinical trials in Pancreatic cancer (First-line therapy, Combination therapy, Metastatic disease) in USA (IV) (NCT03611556)
  • 27 Jul 2018 Committee for Medicinal Products for Human Use grants positive opinion for marketing authorisation for durvalumab for Non-small cell lung cancer (Inoperable/Unresectable, Late-stage disease, Second-line therapy or greater) in European Union
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