VENTANA PD-L1 (SP263) Assay
A widely used PD-L1 stain, approved with durvalumab and later as the test for adjuvant atezolizumab in lung cancer.
Overview
Approved 1 May 2017 (PMA P160046) alongside durvalumab in urothelial carcinoma as a complementary test, SP263 became a companion diagnostic in 2021 for adjuvant atezolizumab in resected stage II-IIIA non-small-cell lung cancer with PD-L1 on at least 1% of tumour cells (IMpower010). In Europe the CE-IVD version carries claims for pembrolizumab, nivolumab and durvalumab across lung, bladder and head and neck cancers, and SP263 is the assay most often shown to be concordant with 22C3 in harmonisation studies. Laboratories frequently validate SP263 as a single platform for several drugs.
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2017 | Complementary PD-L1 assay for durvalumab in urothelial carcinoma |
| US | 2021 | Companion diagnostic for adjuvant atezolizumab in PD-L1 TC ≥1% resected NSCLC |
| EU | 2017 | CE-IVD with claims for several PD-1/PD-L1 antibodies |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Notes
top- What a result means: the percentage of tumour cells that stain; higher scores generally predict more benefit from immunotherapy, and thresholds differ by drug and cancer.
Latest papers
topQuery for this drug: (TITLE:"VENTANA PD-L1 SP263 Assay" OR ABSTRACT:"VENTANA PD-L1 SP263 Assay" OR TITLE:"VENTANA PD-L1" OR ABSTRACT:"VENTANA PD-L1" OR TITLE:"SP263" OR ABSTRACT:"SP263") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about VENTANA PD-L1 (SP263) Assay, not a curated reading list.
Pages like this
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