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Durvalumab - Celgene/MedImmune

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Drug Profile

Durvalumab - Celgene/MedImmune

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

Latest Information Update: 21 Aug 2024

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At a glance

  • Originator MedImmune
  • Developer AIO Studien gGmbH; AstraZeneca; AVEO Oncology; Big Ten Cancer Research Consortium; Biocompatibles International; Canadian Cancer Trials Group; Cancer Research UK; Case Comprehensive Cancer Center; Celgene Corporation; Celgene International SARL; Centre hospitalier de l'Universite de Montreal; Centre Leon Berard; Charite - Universitatsmedizin Berlin; Childrens Hospital Los Angeles; Daiichi Sankyo Company; Dana-Farber Cancer Institute; Eli Lilly and Company; European Network of Gynaecological Oncological Trial Groups; Fondazione IRCCS Istituto Nazionale dei Tumori; Gradalis; Grand Hopital de Charleroi; Grupo Espanol de Tumores Neuroendocrinos; GSK; Gustave Roussy; Immunocore; Innate Pharma; Institut Claudius Regaud; Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori; Jules Bordet Institute; 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; Myriad Genetic Laboratories; National Cancer Institute (USA); National Health and Medical Research Council; NHS Greater Glasgow and Clyde; Nordic Society of Gynaecological - Clinical Trial Unit; Northwestern University; Pharmacyclics; Radboud University; Samsung Medical Center; Spanish Oncology Genito-Urinary Group; Swiss Group for Clinical Cancer Research; SWOG; UNC Lineberger Comprehensive Cancer Center; Undisclosed; UNICANCER; University College London; University Health Network; University of Colorado at Denver; University of Kansas Medical Center; 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; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action Programmed cell death-1 ligand-1 inhibitors; T lymphocyte stimulants
  • Orphan Drug Status

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

    Yes - Biliary cancer; Small cell lung cancer; Liver cancer
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Non-small cell lung cancer; Small cell lung cancer
  • Registered Biliary cancer; Endometrial cancer; Liver cancer; Urogenital cancer
  • Phase III Bladder cancer; Cervical cancer; Fallopian tube cancer; Gastric cancer; Head and neck cancer; Malignant-mesothelioma; Oesophageal cancer; Ovarian cancer; Peritoneal cancer; Renal cell carcinoma; Solid tumours; Triple negative breast cancer
  • Phase II/III Pancreatic cancer
  • Phase II Acute myeloid leukaemia; Brain metastases; Breast cancer; Cholangiocarcinoma; Colorectal cancer; Diffuse large B cell lymphoma; Gallbladder cancer; Germ cell cancer; Glioblastoma; HER2 negative breast cancer; Malignant melanoma; Multiple myeloma; Myelodysplastic syndromes; Neuroendocrine tumours; Non-Hodgkin's lymphoma; Oropharyngeal cancer; Prostate cancer; Sarcoma; Soft tissue sarcoma; Squamous cell cancer; Uterine cancer
  • Phase I/II Chronic lymphocytic leukaemia; Cutaneous T-cell lymphoma; Haematological malignancies; Lung cancer; Lymphoma; Peripheral T-cell lymphoma; Renal cancer
  • No development reported CNS cancer; Gastrointestinal cancer; Lymphoproliferative disorders; Thyroid cancer; Vulvovaginal cancer

Most Recent Events

  • 16 Aug 2024 US FDA approves sBLA for Non-small cell lung cancer (Adjuvant therapy, In adults, In the elderly, Newly diagnosed, First-line therapy, Neoadjuvant therapy) in USA (IV)
  • 15 Aug 2024 Preregistration for Small cell lung cancer (Combination therapy, Early-stage disease, Mid-stage disease, Second-line therapy or greater) in USA (IV)
  • 15 Aug 2024 Durvalumab - Celgene/MedImmune receives Breakthrough Therapy status for Small cell lung cancer in USA

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