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Spartalizumab - Novartis Oncology

Drug Profile

Spartalizumab - Novartis Oncology

Alternative Names: PDR 001

Latest Information Update: 23 Aug 2021

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At a glance

  • Originator Novartis
  • Developer EUSA Pharma; Novartis; Novartis Oncology
  • 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 Breast 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 Acute myeloid leukaemia; Lymphoma; Multiple myeloma; Myelodysplastic syndromes; Myelofibrosis; Ovarian cancer; Renal cancer; Renal cell carcinoma; Squamous cell cancer
  • Discontinued Neuroendocrine tumours

Most Recent Events

  • 28 Jul 2021 Novartis completes a phase I tial in Non-small cell lung cancer (Combination therapy, Late-stage disease, Metastatic disease) in Belgium, Canada, Czech Republic, France, Germany, Hong Kong, Italy, South Korea, Netherlands, Spain, Singapore and USA (IV) (NCT03064854)
  • 24 Jul 2021 3583184- updated KDM, clinical (TT, AE, PK, PD), HE created
  • 25 Jun 2021 Novartis completes phase I/II trial for Liver cancer (Late-stage disease, Combination therapy, Metastatic disease, Second-line therapy or greater) in Canada, China, France, Germany, Hong Kong, Italy, South Korea, Taiwan (IV) (NCT02795429)
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