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Spartalizumab - Novartis Oncology

Drug Profile

Spartalizumab - Novartis Oncology

Alternative Names: PDR 001

Latest Information Update: 25 Jan 2024

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At a glance

  • Originator Novartis
  • Developer EUSA Pharma; Novartis; Novartis Oncology; SOLTI Breast Cancer Research Group; Yonsei University
  • Class Antineoplastics; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; Programmed cell death-1 receptor antagonists; T lymphocyte stimulants
  • Orphan Drug Status

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

    Yes - Pancreatic cancer
  • New Molecular Entity Yes

Highest Development Phases

  • Phase II Anal cancer; Breast cancer; Cancer; Colorectal cancer; Diffuse large B cell lymphoma; Gastric cancer; Malignant melanoma; Nasopharyngeal cancer; Non-small cell lung cancer; Oesophageal cancer; Pancreatic cancer; Solid tumours
  • Phase I/II Gastrointestinal stromal tumours; Liver cancer; Prostate cancer
  • Phase I Renal cell carcinoma
  • No development reported Acute myeloid leukaemia; Lymphoma; Multiple myeloma; Myelodysplastic syndromes; Myelofibrosis; Ovarian cancer; Renal cancer; Squamous cell cancer
  • Discontinued Neuroendocrine tumours

Most Recent Events

  • 27 Dec 2023 Novartis Pharmaceuticals terminates a phase I trial for Solid tumours in Belgium, Germany, Italy, Japan, Multinational, Spain, Taiwan, USA (NCT04261439)
  • 28 Nov 2023 No recent reports of development identified for phase-I development in Acute-myeloid-leukaemia(Combination therapy, Second-line therapy or greater) in Australia (IV)
  • 28 Nov 2023 No recent reports of development identified for phase-I development in Acute-myeloid-leukaemia(Combination therapy, Second-line therapy or greater) in Finland (IV)
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