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Durvalumab - AstraZeneca/Celgene

Drug Profile

Durvalumab - AstraZeneca/Celgene

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

Latest Information Update: 05 Oct 2026

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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; Janssen Research & Development; 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 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 B7-H1 antigen 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 Bladder cancer; Non-small cell lung cancer; Small cell lung cancer
  • Registered Biliary cancer; Endometrial cancer; Gastric cancer; Liver cancer; Oesophageal cancer; Urogenital cancer
  • Phase III Cervical cancer; Fallopian tube cancer; Head and neck cancer; Malignant-mesothelioma; Ovarian cancer; Peritoneal cancer; 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; Renal cell carcinoma
  • No development reported CNS cancer; Gastrointestinal cancer; Lymphoproliferative disorders; Thyroid cancer; Vulvovaginal cancer

Most Recent Events

  • 25 Sep 2026 FDA assigns PDUFA action date of (31/12/2026) for durvalumab for Bladder cancer
  • 25 Sep 2026 US FDA accepts sBLA for durvalumab for Bladder cancer (Neoadjuvant therapy, Combination therapy, First-line therapy) for review
  • 01 Sep 2026 AstraZeneca completes phase III ADJUVANT trial in Non-small cell lung cancer (Adjuvant therapy) in Taiwan, Spain, Singapore, New Zealand, Netherlands, South Korea, Japan, Italy, France, Australia, USA, Romania, Ukraine, Poland, Hungary, China, Bulgaria, Bulgaria, Brazil (NCT02273375)

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