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Spartalizumab - Novartis Oncology

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Drug Profile

Spartalizumab - Novartis Oncology

Alternative Names: PDR 001

Latest Information Update: 16 May 2025

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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

  • 29 Apr 2025 Novartis terminates phase-III clinical trials in Malignant melanoma (Combination therapy, First-line therapy, Inoperable/Unresectable, Metastatic disease) in US, Belgium, Brazil, Bulgaria, Canada, Chile, Czech Republic,Denmark, France, Greece, Hungary, Israel, Italy, Japan, Mexico, the Netherlands, Norway, Poland, Portugal, Russia, Thailand, Argentina, Germany, Austria, Spain, Sweden, Switzerland, the UK and Australia (IV) due to Sponsor's decision (NCT02967692)
  • 13 Jan 2025 Novartis Pharmaceuticals terminates a phase I trial for Solid tumours (Combination therapy, Late-stage disease, Metastatic disease) in US, Canada, France, Israel, Italy, Japan, Singapore, Spain and Taiwan (NCT02936102)
  • 06 Jan 2025 Spartalizumab is still in phase I trials for in Renal cell carcinoma (Combination therapy, Late-stage disease, Second-line therapy or greater) in USA, Singapore, Italy, France, Japan, Spain, Czech Republic (IV) (NCT04895748, EudraCT2020-004383-25)

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