Drug Profile

Spartalizumab - Novartis Oncology

Alternative Names: PDR 001

Latest Information Update: 27 Mar 2026

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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

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

13 Feb 2026 Novartis Pharmaceuticals terminates phase-I trial in Renal cell carcinoma (Late-stage disease, Metastatic disease, Second-line therapy or greater, Monotherapy, Inoperable/Unresectable) in Czech Republic, France, Italy, Japan, Singapore, Spain, USA (PO) due to business decision and not related to safety concerns (NCT04895748)
02 Feb 2026 Ruijin Hospital plans a phase II trial for Extranodal-NK-T-cell-lymphoma (Early stage disease, First line therapy) (IV) in China in February 2025 (NCT07380984)
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)

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