Drug Profile

Spartalizumab - Novartis Oncology

Alternative Names: PDR 001

Latest Information Update: 25 Aug 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

02 Jun 2026 Efficacy, adverse events, pharmacokinetics data from phase I/II trial in Solid tumours presented at the 62nd Annual Meeting of the American Society of Clinical Oncology (ASCO-2026)
29 May 2026 Novartis and Centre Hospitalier Universitaire de Besancon completes a phase-II clinical trials in Anal cancer (Combination therapy, Metastatic disease) in France (IV) (NCT04894370)
22 Apr 2026 Efficacy and adverse events data from a phase II trial in Non small cell lung cancer at 117th Annual Meeting of the American Association for Cancer Research (AACR-2026)

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